Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
600
Countries
12
Sites
121
Previously Untreated Advanced or Metastatic Non-Squamous Non−Small Cell Lung Cancer
To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to progression-free survival (PFS) and overall survival (OS)
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 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-21
- 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 and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to progression-free survival (PFS) and overall survival (OS)
Secondary objectives 5
- To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to confirmed objective response
- To evaluate, from the participant's perspective, symptoms and functioning of participants treated with divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin
- To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to duration of response (DOR)
- To evaluate the safety and tolerability of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin
- To evaluate, from the participant’s perspective, health-related quality of life, functioning, and symptoms of participants treated with divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin
Conditions and MedDRA coding
Previously Untreated Advanced or Metastatic Non-Squamous Non−Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10069759 | KRAS mutation | 10018065 |
| 27.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with assessment scale
- Life expectancy of at least 12 weeks
- Measurable disease, as defined by RECIST v1.1
- No prior systemic treatment for advanced or metastatic non−small cell lung cancer (NSCLC)
- Documentation of the presence of a KRAS G12C mutation either through central laboratory testing of a tumor tissue sample (as per local IVD regulations), or preexisting test results of a blood or tumor tissue sample
- Histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
Exclusion criteria 6
- Symptomatic, untreated, or actively progressing CNS metastases
- Known concomitant second oncogenic driver with available targeted treatment
- Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
- Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the study
- Palliative radiation to bone metastases within 2 weeks prior to randomization to ensure adequate recovery from the effects of radiotherapy
- Significant cardiovascular disease within 3 months prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- PFS, defined as the time from randomization to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)
- OS, defined as time from randomization to death from any cause
Secondary endpoints 10
- Confirmed objective response, defined as CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1
- Change from baseline to Cycle 5 Day 1 on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13 cough item (item 31), the QLQ-C30 dyspnea item (item 8), and the QLQ-C30 Physical Functioning scale (items 1−5)
- DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause, whichever occurs first
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale
- Change from baseline in selected vital signs and ECG parameters
- Change from baseline in selected clinical laboratory test results
- Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE
- Worst post-baseline scores in the severity of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE
- Frequency of participant’s response of the degree they are troubled with treatment symptoms, as assessed by the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
- Change from baseline on the EORTC QLQ-C30 and QLQ-LC13 functional and global health status (GHS)/quality of life (QoL) scales, and symptoms to Cycle 5 Day 1 and throughout the trial
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD11168991 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11081695 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11081693 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11168990 · Product
- Active substance
- Divarasib
- Other product name
- GDC-6036
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081132 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Comparator 13
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Cisplatin-Ebewe, 1 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji
PRD771236 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 19903
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
PRD415238 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 34009 579 377 8 2
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD11884224 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 71983.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
PRD415259 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 34009 576 157 7 2
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505444 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/005
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936183 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/004
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion
PRD4287596 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/002
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion
PRD415296 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 34009 572 558 7 9
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung
PRD2832939 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 86830.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD11854707 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 84223.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1969079 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46297.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Auxiliary 1
Budenofalk 3mg magensaftresistente Hartkapseln
PRD808682 · Product
- Active substance
- Budesonide
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A07EA06 — BUDESONIDE
- Marketing authorisation
- 81258.00.00
- MA holder
- DR. FALK PHARMA G.M.B.H.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
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 5
| Organisation | City, country | Duties |
|---|---|---|
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Almac Group Limited ORG-100011829
|
Craigavon, United Kingdom (Northern Ireland) | Interactive response technologies (IRT) |
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
12 EU/EEA countries · 121 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 16 | 8 |
| Denmark | Ongoing, recruiting | 10 | 6 |
| France | Ongoing, recruiting | 34 | 14 |
| Germany | Ongoing, recruiting | 59 | 27 |
| Greece | Ongoing, recruiting | 18 | 7 |
| Hungary | Ongoing, recruiting | 10 | 5 |
| Ireland | Ongoing, recruiting | 8 | 4 |
| Italy | Ongoing, recruiting | 40 | 14 |
| Netherlands | Ongoing, recruiting | 10 | 7 |
| Poland | Ongoing, recruiting | 32 | 10 |
| Portugal | Ongoing, recruiting | 10 | 4 |
| Spain | Ongoing, recruiting | 35 | 15 |
| Rest of world
United Kingdom, Canada, Singapore, Taiwan, Brazil, New Zealand, Hong Kong, Argentina, China, Switzerland, Australia, United States, Korea, Republic of, Japan, South Africa, Mexico
|
— | 318 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Medical oncology, Avenue De L'Hopital 1, 4000, Liege
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Cliniques Universitaires Saint-Luc
Medical oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Delta
Department of respiratory diseases, Deltalaan 1, 8800, Roeselare
Azorg
Pneumology, Moorselbaan 164, 9300, Aalst
CHU Helora
Oncology, Boulevard President Kennedy 2, 7000, Mons
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Zealand University Hospital
Onkologisk afdeling, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
Onkologisk afdeling, Blegdamsvej 9, 2100, Copenhagen Oe
Region Syddanmark
Onkologisk afdeling, Sydvang 1, 6400, Soenderborg
Aarhus Universitetshospital
Onkologisk afdeling, Palle Juul-Jensens Boulevard 99, 8200, Århus
Herlev og Gentofte Hospital
Onkologisk afdeling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Regionshospitalet Goedstrup
Onkologisk afdeling, Hospitalsparken 15, 7400, Herning
Centre Hospitalier Bretagne Atlantique
Pneumology, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Pneumology, 185 Rue Raymond Losserand, 75014, Paris
Centre Francois Baclesse
Pneumology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Montpellier
Pneumology, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Centre Leon Berard
Pneumology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier De Saint-Quentin
Pneumology, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Centre Antoine Lacassagne
Medical Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier Regional D'Angers
Pneumology, 4 Rue Larrey, 49100, Angers
Les Hopitaux Universitaires De Strasbourg
Medical Oncology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Assistance Publique Hopitaux De Paris
ONCOLOGY, 4 Rue De La Chine, 75020, Paris
Assistance Publique Hopitaux De Paris
ONCOLOGY, 125 Rue De Stalingrad, 93009, Bobigny Cedex
Centre Hospitalier Universitaire Reims
Pneumology, 45 Rue Cognacq Jay, 51092, Reims Cedex
Hospices Civils De Lyon
Pneumology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
LungenClinic Grosshansdorf GmbH
NA, Woehrendamm 80, 22927, Grosshansdorf
Universitaetsklinikum Regensburg AöR
Innere Medizin III - Kardiologie, Pneumologie, intern. Intensivmedizin, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Innere Medizin II - Pneumologie, Roentgenstrasse 1, Doelau, Halle (saale)
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik f. Innere Medizin - Hämatologie, Onkologie u. Palliativmedizin, Landsberger Allee 49, Friedrichshain, Berlin
SLK-Kliniken Heilbronn GmbH
Fachklinik Löwenstein, Geisshoelzle 62, Hirrweiler, Loewenstein
KEM I Evang. Kliniken Essen-Mitte gGmbH
Evang. Huyssens-Stiftung Essen-Huttrop, Henricistrasse 92, Huttrop, Essen
Vincentius-Diakonissen-Kliniken gAG
Med. Klinik 2, Klinik f. Hämatologie, Onkologie, Immunologie u. Intensivmedizin, Suedendstrasse 32, Suedweststadt, Karlsruhe
Universitaetsklinikum Schleswig-Holstein AöR
Studienzentrum Pneumologie, Med. Klinik III, Ratzeburger Allee 160, 23538, Luebeck
Asklepios Klinik Gauting GmbH
Lungenklinik, Robert-Koch-Allee 2, 82131, Gauting
Pius-Hospital Oldenburg
Klinik f. Hämatolgie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
Klinikum Wuerzburg Mitte gGmbH
Schwerpunkt Pneumologie u. Beatmungsmedizin, Salvatorstrasse 7, Frauenland, Wuerzburg
Charite Universitaetsmedizin Berlin KöR
Med. Klinik Infektionologie u. Pneumologie - Campus Virchow Klinikum, Augustenburger Platz 1, Wedding, Berlin
Klinikum Esslingen GmbH
Innere Medizin, Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Lungenfachklinik Immenhausen
Zentrum für Pneumologie, Robert Koch Strasse 3, 34376, Immenhausen
Universitaetsklinikum Mannheim GmbH
Abt. personalisierte Onkologie, Schwerpunkt Lungenkarzinom, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
University Medical Center Hamburg-Eppendorf
Zentrum f. Onkologie II, Med. Klinik u. Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum des Saarlandes AöR
Klinik f. Innere Medizin V - Pneumologie, Allergologie, Beatmungs- u. Umweltmedizin, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Thoraxklinik Heidelberg gGmbH
Gebäude 1, Roentgenstrasse 1, Rohrbach, Heidelberg
Klinikum Region Hannover GmbH
Klinik f. Pneumologie, Intesiv- u. Schlafmedizing, Stadionbruecke 4, Linden-Sued, Hanover
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Med. Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Muenchen Klinik gGmbH
Klinikum Bogenhausen, Klinik f. Pneumologie u. Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Universitaet Muenster
Gebäude 1A Ebene 15A West Studienbüro, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Asklepios Kliniken Hamburg GmbH
Lungenzentrum Hamburg - Pneumologie, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
Universitaetsklinikum Tuebingen AöR
Innere Medizin VIII - Med. Onkol. und Pneumologie, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis
Innere Medizin I, Biedermannstrasse 84, Connewitz, Leipzig
HELIOS Klinikum Emil von Behring GmbH
Klinik für Pneumologie - Lungenklinik Heckeshorn, Walterhoeferstrasse 11, Zehlendorf, Berlin
Henry Dunant Hospital Center
4th Oncology Department, 107 Mesogeion Avenue, 115 26, Athens
Theageneio Cancer Hospital
Β Chemotherapy Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Alexandra Hospital
Medical Oncology Unit Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
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
Oncology Clinic, P. O. Box 1425, 411 10, Larissa
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Reformatus Pulmonologiai Centrum
Onkologiai Ambulancia, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Semmelweis University
Pulmonologiai Klinika, Tomo Utca 25-29, 1083, Budapest VIII
Matrai Gyogyintezet
NA, Matrahaza Hrsz 7151, 3200, Gyongyos
Orszagos Koranyi Pulmonologiai Intezet
XIV. Pulmonologiai Osztaly, Koranyi Frigyes Ut 1, 1121, Budapest XII
University Of Pecs
Onkoterapias Klinika, Edesanyak Utja 17, 7624, Pecs
Mater Misericordiae University Hospital
Clinical Trials Research Unit, Eccles Street, D07 R2WY, Dublin 7
Beaumont Hospital
Cancer Clinical Trials & Research Unit, Beaumont Road, Beaumont, Dublin 9
St James's Hospital
Cancer Clinical Trials Office, James's Street, D08 NHY1, Dublin 8
Tallaght University Hospital
Oncology/Haematology Clinical Trials, Tallaght, D24 NR0A, Dublin 24
Humanitas Istituto Clinico Catanese S.p.A.
Oncologia e Ematologia, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
Istituto Europeo Di Oncologia S.r.l.
Oncologia Toracica, Via Giuseppe Ripamonti 435, 20141, Milan
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Oncologia Toracica, Via Monte Baldo 24, 37019, Peschiera Del Garda
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Toracico-Polmonare, Via Mariano Semmola 52, 80131, Naples
ASST Grande Ospedale Metropolitano Niguarda
Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Di Riferimento Oncologico Di Aviano
Oncologia, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Dei Colli
Pneumologia Oncologica, Via Leonardo Bianchi, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia, Largo Francesco Vito 1, 00168, Rome
San Camillo Forlanini Hospital
Oncologia, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Oncologia, Viale Vittorio Alfieri 36, 57124, Leghorn
Azienda Ospedaliero Universitaria Di Modena
Oncologia, Largo Del Pozzo 71, 41124, Modena
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Oncologia, Via Lombroso S/N, 61122, Pesaro
Azienda Sanitaria Locale Di Taranto
Oncologia, Via Bruno, 72100, Taranto
Fondazione IRCCS San Gerardo Dei Tintori
Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Isala Klinieken Stichting
Lung Diseases, Dokter Van Heesweg 2, 8025 AB, Zwolle
Haaglanden Medisch Centrum Stichting
Lung, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Lung Diseases, Plesmanlaan 121, 1066 CX, Amsterdam
Amphia Hospital
Lung Diseases, Molengracht 21, 4818 CK, Breda
Ziekenhuis St Jansdal
Lung Diseases, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Meander Medisch Centrum
Lung, Maatweg 3, 3813 TZ, Amersfoort
Rijnstate Ziekenhuis Stichting
Lung Diseases, Wagnerlaan 55, 6815 AD, Arnhem
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej (Nowotworów Klatki Piersiowej), Ul. Grabiszynska 105, 53-439, Wroclaw
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Poradnia Onkologiczna, Ul. Koscielna 61, 05-135, Wieliszew
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej, Ul. Pradnicka 80, 31-202, Cracow
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
National Institute Of Tuberculosis And Lung Diseases
III Klinika Chorób Płuc i Onkologii, Ul. Plocka 26, 01-138, Warsaw
Radomskie Centrum Onkologii
Kliniczny Oddział Chemioterapii, Ul. Uniwersytecka 6A, 26-600, Radom
Centrum Pulmonologii I Torakochirurgii W Bystrej
Oddział Pulmonologiczno-Onkologiczny z Chemioterapią, Ul. Juliana Falata 2, Bystra, Wilkowice
CCAB Centro Clinico Academico Braga Associacao
Serviço de Oncologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Gaia/Espinho E.P.E.
Serviço de Pneumologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Loures-Odivelas EPE
Centro de Investigação e Inovação, Avenida Carlos Teixeira, 2674-514, Loures
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Belgium | 2025-12-02 | 2025-12-24 | |||
| Denmark | 2025-11-17 | 2026-03-31 | |||
| France | 2025-11-12 | 2025-11-26 | |||
| Germany | 2025-10-28 | 2025-11-06 | |||
| Greece | 2025-12-17 | 2026-01-09 | |||
| Hungary | 2025-11-24 | 2025-12-16 | |||
| Ireland | 2026-01-16 | 2026-01-28 | |||
| Italy | 2025-12-05 | 2025-12-19 | |||
| Netherlands | 2025-12-01 | 2026-02-04 | |||
| Poland | 2025-10-29 | 2025-11-03 | |||
| Portugal | 2025-11-07 | 2025-11-17 | |||
| Spain | 2025-11-28 | 2025-12-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-129868
- Sponsor became aware
- 2026-04-16
- Date of breach
- 2026-04-16
- Submission date
- 2026-04-20
- Member states concerned
- Germany, Belgium, Denmark, France, Greece, Hungary, Ireland, Italy, Portugal, Spain, Netherlands, Poland
- Categories
- Protocol
- Areas impacted
- Subject safety, Subject rights
- Benefit-risk balance changed
- No
- Description
- On 11Mar2026, patient 10086 was administered with 2 kits of Pembrolizumab (Batch id: 1189276, expiration date: 31-Dec-2026) that were subsequently found to be stored potentially out‐of‐specification storage conditions.
Following review of the refrigerator temperature logs, provided to CRA on 25Mar2026, multiple and systematic data registration gaps were identified during the following periods:
- 05Mar202614:20 to 09Mar2026 10:20
- 11Mar2026 14:25 to 13Mar2026 12:45
- 18Mar2026 14:35 to 20Mar2026 12:45
- 20Mar2026 14:45 to 25Mar2026 10:50.
Due to these extended gaps, it was not possible to retrospectively confirm that the refrigerator operated within the protocol‐ and label‐specified temperature range during the storage of the administered kits.
The root cause is under formal investigation by clinical engineering at the local hospital.
On 25Mar2026, following the submission of a stability assessment request (PD103), the Sponsor officially declared the IMP stored during this period as "Not fit for Use". Consequently, the patient received a product whose quality could not be guaranteed at the time of administration.
A fatal event occurred on 11Mar2026; however the clinical staff has assessed this event as not related to the investigational products. - Sponsor actions
- Requested the disposal of all pembrolizumab vials (7 vials with Batch ID: 1189276, expiration: December 31, 2026) according to site’internal procedures. Sponsor received the disposal report.
The site confirmed the return to the full functionality of the equipment. However the result of the Clinical Engineering analysis regarding the cause of the registration gaps and confirmation of current full functionality of the refrigerator should be included in the CAPA.
| Organisation | City | Country | Type |
|---|---|---|---|
| Ospedale S G Moscati | Statte | Italy | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 134 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2024-518365-10-00-redacted | 2 |
| Protocol (for publication) | d1_protocol-2024-518365-10-00-redacted GR | 2 |
| Protocol (for publication) | d4_Patient facing documents_Redaction Memo | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_CO45042_Recruitment and Informed consent procedure_Hungary | March 2023 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CO45042 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangments | 1 |
| Recruitment arrangements (for publication) | K2_CO45042_flyer | 3 |
| Recruitment arrangements (for publication) | K2_Document additionnel | 1 |
| Recruitment arrangements (for publication) | K2_Patient_Card | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material patient flyer | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Leaflet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Experience Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP referral letter | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Leaftlet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient flyer_EN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient flyer_FR | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Flyer_ITA | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient flyer_NL | 1 |
| Recruitment arrangements (for publication) | K2_ROC_Flyer-Patienten_mit_Link_CO45042 | 1 |
| Recruitment arrangements (for publication) | K2_Social Media Post v1_CO45042 | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Flyer | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF IAF | 3 |
| 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 biopsy REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PPA REDACTED | 2 |
| 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 RBR REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Continuation | 2 |
| Subject information and informed consent form (for publication) | L1_Apparent Disease Worsening | 1 |
| Subject information and informed consent form (for publication) | L1_Appendix 1 - GDPR_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_GDPR | 2 |
| Subject information and informed consent form (for publication) | L1_IAF | 2 |
| 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 | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Biopsy_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Optional RBR_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ Pregnant Partner Authorization_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Infant Health Sharing | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_Treatment_Continuation | 1 |
| Subject information and informed consent form (for publication) | L1_Main_ICF_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Opt_Biopsy_ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Pregnant_Partner_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Prescreening_ICF_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1.0 |
| Subject information and informed consent form (for publication) | L1_RBR_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_REDACTED | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF collect data infant | 2.0 |
| 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 Genetic PT_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF PT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorisation | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_CO45042_redacted | 4 |
| 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_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF opt tumor biopsy_CO45042 redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy PT_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional biopsy redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optionele biopten | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA _REDACTED | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_EN_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_FR_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_NL_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRE SCREENING_Redacted | 2 |
| 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 pregnant partner redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_CO45042_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant patient_CO45042_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_CO45042 redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_REDACTED | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR PT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR redacted | 1 |
| 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 RBR_CO45042 redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment continuation post-progression redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF treatment continuation_CO45042 | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject material_Krascendo 2_Dosing Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Krascendo2_ Genentech Brochure WIreframe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Krascendo2_Alert Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Krascendo2_HCP Referral Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient study flyer | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_GP_Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Krascendo 2_Patient Flyer | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Krascendo 2_Patient Safety Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Krascendo 2_Patient Thank You Letter digital | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Krascendo 2_Patient Thank You Letter Print | 1 |
| Subject information and informed consent form (for publication) | L2_Right to not know | 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_Summary for patient materials | 4 |
| Subject information and informed consent form (for publication) | L2_Your Rights as a Trial Participant | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-cisplatin | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-de-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-fr-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-nl-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_gr-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl-nl-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2024-518365-10-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pt-2024-518365-10-00 | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Netherlands | Acceptable 2025-10-20
|
2025-10-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-29 | Acceptable 2025-10-20
|
2025-10-29 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-29 | Acceptable 2025-10-20
|
2025-10-29 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-07 | Netherlands | Acceptable 2025-10-20
|
2025-11-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-13 | Acceptable | 2025-12-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-01 | Netherlands | Acceptable | 2025-12-16 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-13 | Netherlands | Acceptable | 2026-01-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-09 | Netherlands | Acceptable 2026-04-13
|
2026-04-13 |