Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
328
Countries
13
Sites
103
KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
To evaluate the efficacy of divarasib compared with Kirsten rat sarcoma virus oncogene homolog glycine 12 to cysteine (KRAS G12C) inhibitors (sotorasib or adagrasib) with respect to progression-free survival (PFS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche Ltd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Safety
To evaluate the efficacy of divarasib compared with Kirsten rat sarcoma virus oncogene homolog glycine 12 to cysteine (KRAS G12C) inhibitors (sotorasib or adagrasib) with respect to progression-free survival (PFS)
Secondary objectives 6
- To evaluate the efficacy of divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib) with respect to overall survival (OS)
- To evaluate, from the participant's perspective, the functioning and impact of key disease-related symptoms of participants treated with divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib)
- To evaluate the efficacy of divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib) with respect to duration of response (DOR)
- To evaluate the safety and tolerability of divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib)
- To evaluate the quality of life of participants treated with divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib)
- To evaluate the efficacy of divarasib compared with KRAS G12C inhibitors (sotorasib or adagrasib) with respect to confirmed objective response
Conditions and MedDRA coding
KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10069759 | KRAS mutation | 10018065 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003364-PIP02-22
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Measurable disease according to RECIST v1.1
- Documentation of the presence of a KRAS G12C mutation through central laboratory testing of a tumor tissue sample or preexisting test results of a blood or tumor tissue sample
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
- Negative HIV test, Negative hepatitis B surface antigen (HbsAg) test and Negative hepatitis C virus (HCV) antibody test at screening
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion criteria 6
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 7 days after the final dose of sotorasib, or of the final dose of adagrasib or divarasib. Female participants of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.
- Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known concomitant second oncogenic driver
- Mixed small-cell lung cancer or large cell neuroendocrine histology
- Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Progression-free survival (PFS)
Secondary endpoints 12
- 1. Overall survival (OS)
- 2. Confirmed Objective response
- 3. Time to confirmed deterioration (TTCD) on the EORTC QLQ-C30 dyspnea item and the physical functioning scale, and the cough scale of the QLQ-LC13 scales
- 4. Duration of response (DOR)
- 5. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale
- 6. Change from baseline in selected vital signs and ECG parameters
- 7. Change from baseline in selected clinical laboratory test results
- 8. Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic treatment toxicities (diarrhea, nausea, vomiting, anorexia, alopecia, dyspnea, cough, constipation, myalgia, headache, and rash/acne) as assessed through use of the NCI PRO-CTCAE
- 9. Change from baseline in diarrhea, nausea, vomiting, anorexia, alopecia, dyspnea, cough, constipation, myalgia, headache, and rash/acne as assessed through use of the NCI PRO-CTCAE
- 10. Frequency of participants’ response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC Item List (IL46)
- 11. Change from baseline in cough, chest pain, dyspnea, physical and role functioning, and GHS/QoL at each timepoint as assessed through use of the EORTC QLQ-LC13 and QLQ-C30
- 12. TTCD on the EORTC QLQ-C30 role functioning and GHS/QoL scales and TTCD on the chest pain scale of the QLQ-LC13 scales
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
—
PRD11168991 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11168990 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11081693 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11081694 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11081695 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 10
—
PRD11075055 · Product
- Substance synonyms
- 2-[(2S)-4-[7-(8-chloronaphthalen-1-yl)-2-[[(2S)-1-methylpyrrolidin-2-yl]methoxy]-6,8-dihydro-5H-pyrido[3,4-d]pyrimidin-4-yl]-1-(2-fluoroprop-2-enoyl)piperazin-2-yl]acetonitrile, MRTX-849
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/23/1744/001
- MA holder
- MIRATI THERAPEUTICS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
PRD11078995 · Product
- Substance synonyms
- 2-[(2S)-4-[7-(8-chloronaphthalen-1-yl)-2-[[(2S)-1-methylpyrrolidin-2-yl]methoxy]-6,8-dihydro-5H-pyrido[3,4-d]pyrimidin-4-yl]-1-(2-fluoroprop-2-enoyl)piperazin-2-yl]acetonitrile, MRTX-849
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/23/1744/002
- MA holder
- MIRATI THERAPEUTICS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
SUB197397 · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
PRD9412069 · Product
- Substance synonyms
- AMG 510, PYRIDO(2,3-D)PYRIMIDIN-2(1H)-ONE, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-1-(4-METHYL-2-(1-METHYLETHYL)-3-PYRIDINYL)-4-((2S)-2-METHYL-4-(1-OXO-2-PROPEN-1-YL)-1-PIPERAZINYL)-, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-(1M)-1-[4-METHYL-2-(PROPAN-2-YL)PYRIDIN-3-YL]-4-[(2S)-2-METHYL-4-(PROP-2-ENOYL)PIPERAZIN-1-YL]PYRIDO[2,3-D]PYRIMIDIN2(1H)-ONE
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/21/1603/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
PRD9412072 · Product
- Substance synonyms
- AMG 510, PYRIDO(2,3-D)PYRIMIDIN-2(1H)-ONE, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-1-(4-METHYL-2-(1-METHYLETHYL)-3-PYRIDINYL)-4-((2S)-2-METHYL-4-(1-OXO-2-PROPEN-1-YL)-1-PIPERAZINYL)-, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-(1M)-1-[4-METHYL-2-(PROPAN-2-YL)PYRIDIN-3-YL]-4-[(2S)-2-METHYL-4-(PROP-2-ENOYL)PIPERAZIN-1-YL]PYRIDO[2,3-D]PYRIMIDIN2(1H)-ONE
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/21/1603/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
PRD11341702 · Product
- Substance synonyms
- AMG 510, PYRIDO(2,3-D)PYRIMIDIN-2(1H)-ONE, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-1-(4-METHYL-2-(1-METHYLETHYL)-3-PYRIDINYL)-4-((2S)-2-METHYL-4-(1-OXO-2-PROPEN-1-YL)-1-PIPERAZINYL)-, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-(1M)-1-[4-METHYL-2-(PROPAN-2-YL)PYRIDIN-3-YL]-4-[(2S)-2-METHYL-4-(PROP-2-ENOYL)PIPERAZIN-1-YL]PYRIDO[2,3-D]PYRIMIDIN2(1H)-ONE
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/21/1603/004
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
PRD9412070 · Product
- Substance synonyms
- AMG 510, PYRIDO(2,3-D)PYRIMIDIN-2(1H)-ONE, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-1-(4-METHYL-2-(1-METHYLETHYL)-3-PYRIDINYL)-4-((2S)-2-METHYL-4-(1-OXO-2-PROPEN-1-YL)-1-PIPERAZINYL)-, 6-FLUORO-7-(2-FLUORO-6-HYDROXYPHENYL)-(1M)-1-[4-METHYL-2-(PROPAN-2-YL)PYRIDIN-3-YL]-4-[(2S)-2-METHYL-4-(PROP-2-ENOYL)PIPERAZIN-1-YL]PYRIDO[2,3-D]PYRIMIDIN2(1H)-ONE
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/21/1603/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
SUB197397 · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
SUB197397 · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
—
SUB197397 · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Cellcarta Naperville LLC ORG-100042145
|
Naperville, United States | Laboratory analysis |
| Kayentis ORG-100037894
|
Meylan, France | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Foundation Medicine, Inc. ORL-000011855
|
BostonMA 02210, United States | Laboratory analysis |
| Foundation Medicine GmbH ORG-100040499
|
Penzberg, Germany | Laboratory analysis |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Covance Central Laboratory Services Inc. ORG-100018412
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Syneos Health, LLC ORL-000012636
|
Gurugram, India | Data management |
Locations
13 EU/EEA countries · 103 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 11 | 1 |
| Belgium | Ongoing, recruitment ended | 24 | 10 |
| Denmark | Ongoing, recruitment ended | 6 | 3 |
| Finland | Ongoing, recruitment ended | 4 | 3 |
| France | Ongoing, recruitment ended | 33 | 13 |
| Germany | Ongoing, recruitment ended | 30 | 17 |
| Greece | Ongoing, recruitment ended | 20 | 6 |
| Italy | Ongoing, recruitment ended | 34 | 17 |
| Netherlands | Ongoing, recruitment ended | 20 | 6 |
| Poland | Ongoing, recruitment ended | 30 | 12 |
| Portugal | Ongoing, recruitment ended | 12 | 5 |
| Spain | Ongoing, recruitment ended | 22 | 8 |
| Sweden | Ended | 4 | 2 |
| Rest of world
Hong Kong, United States, Argentina, United Kingdom, Taiwan, Brazil, Korea, Republic of, Japan, Singapore, Australia, Mexico, Thailand, Canada
|
— | 78 | — |
Investigational sites
Krankenhaus Nord Klinik Floridsdorf
Department for Respiratory and Critical Care Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
Vitaz
Thoracic oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Cliniques Universitaires Saint-Luc
Medical oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Onze-Lieve-Vrouwziekenhuis
Pneumology, Moorselbaan 164, 9300, Aalst
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pulmonary Division, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Antwerp University Hospital
Thoracic oncology, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Delta
Department of respiratory diseases, Deltalaan 1, 8800, Roeselare
GasthuisZusters Antwerpen
Oncology centre, Oosterveldlaan 24, 2610, Antwerp
Centre hospitalier universitaire de Liege
Medical oncology, Avenue De L'hopital 1, 4000, Liege
Herlev og Gentofte Hospital
Onkologisk afdeling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Regionshospitalet Goedstrup
Onkologisk afdeling, Hospitalsparken 15, 7400, Herning
Aarhus Universitetshospital
Onkologisk afdeling, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Pohjois-Savon hyvinvointialue
Oncology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
HUS-Yhtymae
Clinical trial Unit, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Pulmonogy, Kiinamyllynkatu 4-8, 20520, Turku
Centre Hospitalier Regional Et Universitaire De Brest
PNEUMOLOGY, Boulevard Tanguy Prigent, 29200, Brest
CHU De Bordeauxt
PNEUMOLOGY, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Antoine Lacassagne
ONCOLOGY, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Assistance Publique Hopitaux De Paris
PNEUMOLOGY, 4 Rue De La Chine, 75020, Paris
Hospices Civils De Lyon
PNEUMOLOGY, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Hospitalier Universitaire D'Angers
PNEUMOLOGY, 4 Rue Larrey, 49100, Angers
Centre Leon Berard
PNEUMOLOGY, 28 Rue Laennec, 69008, Lyon
Les Hopitaux Universitaires De Strasbourg
PNEUMOLOGY, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Toulouse
PNEUMOLOGY, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier De Saint-Quentin
PNEUMOLOGY, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Centre Hospitalier Universitaire De Montpellier
PNEUMOLOGY, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Lille
PNEUMOLOGY, Boulevard Du Professeur Jules Leclercq, 59000, Lille
HIA Sainte Anne
PNEUMOLOGY, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Universitaetsklinikum des Saarlandes AöR
Innere Medizin V, Kirrberger Strasse 100, 66421, Homburg
SLK-Kliniken Heilbronn GmbH
Med.Klinik II Onkologie, Geisshoelzle 62, Hirrweiler, Loewenstein
KEM I Evang. Kliniken Essen-Mitte gGmbH
Internistische Onkologie/Hämatologie, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Regensburg AöR
Innere Medizin II - Pneumologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Kliniken der Stadt Koeln gGmbH
Lungenkrebszentrum, Ostmerheimer Strasse 200, Merheim, Cologne
Klinikum Wuerzburg Mitte gGmbH
Innere Medizin, Salvatorstrasse 7, Frauenland, Wuerzburg
Klinikum Esslingen GmbH
Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaetsklinikum Muenster AöR
Internistische Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Essen AöR
Innere Klinik, Hufelandstrasse 55, Holsterhausen, Essen
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Lungenkrebszentrum, Theo-Funccius-Strasse 1, 58675, Hemer
Asklepios Klinik Gauting GmbH
Onkologie, Robert-Koch-Allee 2, 82131, Gauting
HELIOS Klinikum Emil von Behring GmbH
Pneumologie Onkologie u.Infektiologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Thoraxklinik Heidelberg gGmbH
Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Muenchen Klinik gGmbH
Pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Universitaetsklinikum Schleswig-Holstein AöR
Pneumologie - Onkologie, Ratzeburger Allee 160, 23538, Luebeck
LungenClinic Grosshansdorf GmbH
Klinische Studien, Woehrendamm 80, 22927, Grosshansdorf
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Lunge, Lindenberger Weg 27, Buch, Berlin
Theageneio Cancer Hospital
Oncology Clinic, Simeonidi Alex 2, 546 39, Thessaloniki
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Henry Dunant Hospital Center
4th Clinic of Oncology, 107 Mesogeion Avenue, 115 26, Athens
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine/ Oncology Unit, Messogion Avenue 152, 115 27, Athens
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
Azienda Ospedaliera Universitaria Mater Domini
Oncoematology, Viale Pio X 95, 88100, Catanzaro
Istituto Tumori Bari Giovanni Paolo II
Medical Oncology for Thoracic Pathology, Viale Orazio Flacco 65, 70124, Bari
Azienda Sanitaria Universitaria Friuli Centrale
Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliera Dei Colli
UOC of Thoracic Oncology, Via Leonardo Bianchi, 80131, Naples
IRCCS Ospedale Policlinico San Martino
Academic Medical Oncology Unit; Department of Internal Medicine and medical Specialties, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Oncology, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Di Sassari
UOC Oncologia Medica, Via Michele Coppino 26, 07100, Sassari
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia Dipartimento Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
I.F.O. Istituti Fisioterapici Ospitalieri
Clinical Trials Unit: Phase 1 and Precision Medicine, Via Elio Chianesi N 53, 00144, Rome
Careggi University Hospital
SODc Oncologia Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Pisana
Cardio Thoracic Vascular Department - Pneumology Unit_Pneumo-Oncology Service, Via Paradisa 2, 56124, Pisa
Istituto Oncologico Veneto
Medical Oncology 2, Via Gattamelata 64, 35128, Padova
Humanitas Mirasole S.p.A.
Medical Oncology and Hematology Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia Dipartimento Onco-Ematologico, Viale Dante 10, 48022, Lugo
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia Dipartimento Onco-Ematologico, Viale Stradone 9, 48018, Faenza
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
UOC Oncologia, Via Trabucco 180, 90146, Palermo
Medical Center Haaglanden
Longgeneeskunde, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Ziekenhuis St Jansdal
Longgeneeskunde, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Amphia Hospital
Longgeneeskunde, Molengracht 21, 4818 CK, Breda
Rijnstate Ziekenhuis Stichting
Longgeneeskunde, Wagnerlaan 55, 6815 AD, Arnhem
Isala Klinieken Stichting
Longgeneeskunde, Dokter Van Heesweg 2, 8025 AB, Zwolle
Jeroen Bosch Ziekenhuis
Longgeneeskunde, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Centrum Innowacyjnych Terapii, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii I, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej, Ul. Pradnicka 80, 31-202, Cracow
Kliniki Neuroradiochirurgii Sp. z o.o.
Radomskie Centrum Onkologii, Kliniczny Oddział Chemioterapii, Ul. Uniwersytecka 6a, 26-601, Radom
Kujawsko Pomorskie Centrum Pulmonologii W Bydgoszczy
Poradnia Onkologiczna z Ambulatorium Chemioterapii, Ul. Seminaryjna 1, 85-326, Bydgoszcz
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej, Ul. Grabiszynska 105, 53-439, Wroclaw
National Institute Of Tuberculosis And Lung Diseases
III Klinika Chorób Płuc i Onkologii, Ul. Plocka 26, 01-138, Warsaw
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Champalimaud Clinical Centre
Medical Oncology – Lung Cancer Unit, Avenida Brasilia S/n, 1400-038, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Serviço de Oncologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Coimbra E.P.E.
Serviço de Pneumologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Santo Antonio E.P.E.
Centro Académico Clínico ICBAS-CHUdSA, Largo Professor Abel Salazar, 4050-011, Porto
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Unviersitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-12-03 | 2025-01-22 | 2025-08-25 | ||
| Belgium | 2024-11-06 | 2024-11-12 | 2025-08-25 | ||
| Denmark | 2024-09-19 | 2024-10-04 | 2025-08-25 | ||
| Finland | 2025-01-16 | 2025-01-20 | 2025-08-25 | ||
| France | 2024-09-13 | 2024-09-26 | 2025-08-25 | ||
| Germany | 2024-08-28 | 2024-09-24 | 2025-08-25 | ||
| Greece | 2024-10-21 | 2024-10-24 | 2025-08-25 | ||
| Italy | 2024-09-20 | 2024-10-16 | 2025-08-25 | ||
| Netherlands | 2024-09-30 | 2024-10-02 | 2025-08-25 | ||
| Poland | 2024-09-03 | 2024-10-22 | 2025-08-25 | ||
| Portugal | 2024-10-02 | 2024-10-03 | 2025-08-25 | ||
| Spain | 2024-09-26 | 2024-10-10 | 2025-08-25 | ||
| Sweden | 2024-09-09 | 2025-09-17 | 2024-09-11 | 2025-08-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 255 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-510908-37-00 GR Redacted | 3 |
| Protocol (for publication) | D1_Protocol 2024-510908-37-00 Redacted | 3 |
| Protocol (for publication) | D1_Protocol Memo 2024-510908-37-00 Redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_AT-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_BE-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_BE-NL | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_DE-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_ES | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_FR-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_GR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_IT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_PT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Adagrasib_SE-SE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_AT-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_BE-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_BE-NL | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_DE-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_ES | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_FR-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_GR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_IT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_PT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Divarasib_SE-SE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_AT-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_BE-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_BE-NL | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_DE-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_ES | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_FR-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_GR | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_IT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_PT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary Sotorasib_SE-SE | 3 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_AT-DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_BE-FR | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_BE-NL | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_DE-DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_EN | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_ES | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_FR-FR | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_GR | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_IT | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_PT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L_SE-SE | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_IL46_AT-DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL46_BE-FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_BE-NL | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_DE-DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_EN | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_FR-FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_IT | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_PT | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46_SE-SE | N/A |
| Protocol (for publication) | D4_Patient facing documents_IL46L_ES | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_AT-DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_LC13_BE-FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_BE-NL | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_DE-DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_EN | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_ES | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_FR-FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_IT | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_PT | N/A |
| Protocol (for publication) | D4_Patient facing documents_LC13_SE-SE | N/A |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_AT-DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_BE-FR | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_BE-NL | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_DE-DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_EN | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_ES | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_FR-FR | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_GR | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_IT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_PT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-CTCAE_SE-SE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_AT-DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_BE-FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_BE-NL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_DE-DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_EN | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_ES | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_FR-FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_GR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_PT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_QLQ-C30_SE-SE | 3.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_BO45217_DEU_Recruitment Arrangements and Informed Consent Procedure | 2 |
| Recruitment arrangements (for publication) | K1_Document additionel_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangements_AT | 1 |
| Recruitment arrangements (for publication) | K2_BO45217_DEU_Social Media Post_V1_2025-04-08 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Diversity_inclusion leaflet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_referral letter_PH | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Template Communication to Doctors | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Appendix 1 to ICF | 3 |
| Subject information and informed consent form (for publication) | L1_BO45217_DEU_ICF_MAIN_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BO45217_DEU_ICF_OPTIONALE_BIOPSIE | 2 |
| Subject information and informed consent form (for publication) | L1_BO45217_DEU_ICF_RBR | 2 |
| Subject information and informed consent form (for publication) | L1_BO45217_DEU_ICF_VERSCHLECHTERUNG | 2 |
| Subject information and informed consent form (for publication) | L1_BO45217_DEU_ICF_VORUNTERSUCHUNG | 2 |
| Subject information and informed consent form (for publication) | L1_Genom document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Apparent Disease Worsening | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Infant Health | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Biopsy_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Optional RBR_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Prescreening_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subject | 2.0 |
| Subject information and informed consent form (for publication) | L1_Recruitment Arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS Additional Information leaflet Appendix 2 redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Authorisation For The Use and Sharing of Infant Health Information clean | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Authorisation For The Use And Sharing of Pregnancy Health Info | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF collect data infant | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF disease progression | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for the use and sharing of infant health information | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant AF EN | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant AF PT | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Informed Consent Form Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main PT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main research redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_REDACTED | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional biospy | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional EN_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PT | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optionele biopsieen | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening consent form redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-studie onderzoek | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner EN | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner PT | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_EN_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR EN_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Thuisbezoeken | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Zwangere partner | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Consent for Infant Health Data | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Consent for pregnant partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Consent to Mobile Nursing | n/a |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Appendix 1 (Risks)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Appendix 2 (Data integrity)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Appendix 3 (optional biopsy)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Appendix 4 (consent to long term storage)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Appendix 5 (consent to treatment beyond progression) | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant AF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Authorisatie | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_REDACTED | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_optional procedure_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF (alternative 1)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF (alternative 2)_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnant partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment cont after worsening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS Data Privacy Information Sheet Appendix 1 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_General_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_IAF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Mobile Nursing_PH | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Optional Biopsy | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_PPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Prescreening | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_RBR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Infant AF_AT | 1.2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Main_AT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Optional Biopsy_AT_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_PPA_AT | 1.2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Pre-screening_AT_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_RBR_AT_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_TreatmentContinuation_AT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed consent form procedure | 2.0 |
| Subject information and informed consent form (for publication) | L2_Note to File | 1 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use of ICF Model | 1 |
| Subject information and informed consent form (for publication) | L2_Subjects rights | 2 |
| Subject information and informed consent form (for publication) | L2_Subjects rights IVDR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC KRAZATI.pdf | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC LUMYKRAS | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC LUMYKRAS-redline | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT-DE 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT-DE 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE 2024-510908-37-00 Redline.pd | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-NL 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-NL 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT 2024-510908-37-00.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE-SE 2024-510908-37-00 Redline.pdf | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE-SE 2024-510908-37-00.pdf | 2 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Denmark | Acceptable 2024-08-19
|
2024-08-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-09 | Acceptable 2024-08-19
|
2024-09-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-12 | Acceptable | 2024-11-06 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-30 | Acceptable | 2024-11-18 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-19 | Acceptable | 2024-11-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-19 | Denmark | Acceptable 2025-03-18
|
2025-03-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-01 | Denmark | Acceptable 2025-03-18
|
2025-04-01 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-08 | Acceptable | 2025-04-11 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-04-14 | Denmark | Acceptable | 2025-04-14 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-05 | Denmark | Acceptable 2025-09-05
|
2025-09-05 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-12 | Denmark | No conclusion 2026-02-10
|
2026-02-12 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-03-09 | Denmark | No conclusion 2026-02-10
|
2026-03-09 |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-10 | No conclusion | 2026-03-16 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-18 | Denmark | No conclusion | 2026-03-26 |