Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
257
Countries
10
Sites
30
Completely resected, Stage Ib (tumors ≥ 4 cm) to Stage IIIa, Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage Ib (tumors ≥4 cm) to Stage IIIa, ALK-positive NSCLC based on investigator assessed disease-free survival
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
- 9 Aug 2018 → ongoing
- Decision date (initial)
- 2024-05-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-506861-76-00
- EudraCT number
- 2017-004331-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage Ib (tumors ≥4 cm) to Stage IIIa, ALK-positive NSCLC based on investigator assessed disease-free survival
Secondary objectives 4
- To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage Ib (tumors ≥4 cm) to Stage IIIa, ALK-positive NSCLC based on overall survival
- To evaluate the safety and tolerability of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage Ib (tumors ≥ 4 cm) to Stage IIIa, ALK-positive NSCLC
- For alectinib arm only To characterize the pharmacokinetics (PK) of alectinib and its major metabolite(s) in patients with completely resected Stage Ib (tumors≥4 cm) to Stage IIIa, ALK-positive NSCLC
- For alectinib arm only At Japanese sites only: To characterize the pharmacokinetics of alectinib and its major metabolite(s) in Japanese patients
Conditions and MedDRA coding
Completely resected, Stage Ib (tumors ≥ 4 cm) to Stage IIIa, Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Efficacy and safety of Alectinib versus Platinum-Based Chemo in patients with NSCL A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients with Completely Resected Stage Ib (Tumors ≥ 4 Cm) to Stage IIIa Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer
|
Randomised Controlled | None | Experimental arm: Alectinib at 600 mg: Alectinib at 600 mg orally BID taken with food for 24 months. Control arm 1: Cisplatin 75 mg/m2 on Day 1 plus vinorelbine 25 mg/m2 on Days 1 and 8: Patients receive the protocol-specified platinum-based chemotherapy regimens (including all required premedications and permitted concomitant medications) according to the local prescribing information. Control arm 2: Cisplatin 75 mg/m2 on Day 1 plus gemcitabine 1250 mg/m2 on Days 1 and 8: Patients receive the protocol-specified platinum-based chemotherapy regimens (including all required premedications and permitted concomitant medications) according to the local prescribing information. Control arm 3: Cisplatin 75 mg/m2 on Day 1 plus pemetrexed 500 mg/m2 on Day 1: Patients receive the protocol-specified platinum-based chemotherapy regimens (including all required premedications and permitted concomitant medications) according to the local prescribing information. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Complete resection of histologically-confirmed Stage Ib (tumor ≥ 4 cm) to Stage IIIa (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per UICC/AJCC, 7th edition, with negative margins, at 4-12 weeks before enrollment
- Documented ALK-positive disease according to an FDA-approved and CE-marked test
- Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
- Adequate hematologic and renal function
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion criteria 5
- Pregnant or breastfeeding, or intending to become pregnant during the study and for at least 5 weeks after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- Prior adjuvant radiotherapy for NSCLC Prior exposure to systemic anti-cancer therapy and ALK inhibitors
- Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
- Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
- Significant liver disease or impaired liver transaminase enzymes levels, symptomatic bradycardia, any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection, HIV positivity
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Disease-free survival per investigator’s assessment
Secondary endpoints 5
- 1. Overall survival
- 2. Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
- 3. Incidence of abnormal laboratory findings
- 4. Changes in vital signs and electrocardiograms
- 5. Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
SUB00069MIG · Substance
- Active substance
- Vinorelbine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslösung
PRD472665 · Product
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 10000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 71399.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433080 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin ACTAVIS 10 mg/ml concentrat pentru soluţie perfuzabilă
PRD4882377 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 9544/2016/03
- MA holder
- TEVA B.V
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD664576 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 44922.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5956678 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 876 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4815708 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 876 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 84 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
- 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 8
| Organisation | City, country | Duties |
|---|---|---|
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Other |
| Axon Communications Inc. ORG-100048038
|
Toronto, Canada | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Fortrea Inc. ORG-100012602
|
Bannockburn, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
Locations
10 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 5 | 1 |
| Denmark | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 6 | 3 |
| Germany | Ongoing, recruitment ended | 6 | 4 |
| Greece | Ongoing, recruitment ended | 2 | 2 |
| Hungary | Ongoing, recruitment ended | 2 | 2 |
| Italy | Ongoing, recruitment ended | 15 | 5 |
| Poland | Ongoing, recruitment ended | 8 | 4 |
| Romania | Ongoing, recruitment ended | 2 | 2 |
| Spain | Ongoing, recruitment ended | 7 | 6 |
| Rest of world
Thailand, United Kingdom, Russian Federation, Kazakhstan, Belarus, Taiwan, China, Israel, Japan, Bosnia and Herzegovina, Australia, Turkey, Ukraine, United States, Egypt, Korea, Republic of
|
— | 202 | — |
Investigational sites
Krankenhaus Nord Klinik Floridsdorf
Department for Respiratory and Critical Care Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
Centre Hospitalier Universitaire D'Angers
Service de Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional De Marseille
Oncologie Multidisciplinaire et Innovations thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Gustave Roussy
Service d'Oncologie Thoracique, 114 Rue Edouard Vaillant, 94800, Villejuif
Klinikum Chemnitz gGmbH
Innere Medizin IV, Flemmingstrasse 2, Altendorf, Chemnitz
Thoraxklinik Heidelberg gGmbH
Thoraxklinik, Roentgenstrasse 1, Rohrbach, Heidelberg
Franziskus Hospital Harderberg
Klinik für Thoraxonkologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Lungenfachklinik Immenhausen
Pneumologische Onkologie, Robert-Koch-Str. 3, 34376, Immenhausen
Theageneio Cancer Hospital
Oncology Clinic, Simeonidi Alex 2, 546 39, Thessaloniki
Metropolitan Hospital
Β΄ Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Onkológiai központ, Toszegi Ut 21, 5000, Szolnok
Orszagos Onkologiai Intezet
Belgyógyászati-Onkológiai Osztály és Klinikai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
San Camillo Forlanini Hospital
Unità Operativa Complessa di Pneumologia Oncologica 1, Circonvallazione Gianicolense 87, 00152, Rome
Hospital Santa Maria Della Misericordia
Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncologia, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Malattie Apparato Respiratorio 5 ad Indirizzo Oncologico, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Dei Colli
Pneumologia Oncologica, Via Leonardo Bianchi, 80131, Naples
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział onkologii z pododdziałem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Hospital Universitario La Paz
Oncología, Paseo Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital De La Santa Creu I Sant Pau
Oncología, Carrer De San Quinti 89, 08041, Barcelona
Hospital Clinico Universitario De Valencia
Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Germans Trias I Pujol
Oncología, Carretera Canyet 1a Planta, 08916, Badalona
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 | 2018-11-12 | 2018-11-16 | 2021-10-29 | ||
| Denmark | 2018-09-27 | 2019-02-27 | 2021-10-29 | ||
| France | 2018-11-26 | 2019-02-07 | 2021-10-29 | ||
| Germany | 2019-01-08 | 2019-01-31 | 2021-10-29 | ||
| Greece | 2018-12-11 | 2019-01-22 | 2021-10-29 | ||
| Hungary | 2018-10-29 | 2018-12-18 | 2021-10-29 | ||
| Italy | 2018-10-04 | 2019-01-04 | 2021-10-29 | ||
| Poland | 2018-08-28 | 2018-09-20 | 2021-10-29 | ||
| Romania | 2020-10-30 | 2021-03-26 | 2021-10-29 | ||
| Spain | 2018-08-09 | 2018-12-11 | 2021-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 97 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | Redacted CSR - ALECENSA - Oncology | 1 |
| Protocol (for publication) | D1_Protocol 2023-506861-76-00 GR Redacted | 8 |
| Protocol (for publication) | D1_Protocol 2023-506861-76-00 Redacted.pdf | 8 |
| Protocol (for publication) | d4_patient-facing-documents_memo | 3 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement_BO40336 | 1 |
| Recruitment arrangements (for publication) | K1_BO40336_DEU_Recruitment Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arragements_blank | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_NTF | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NTF | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NTF | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NTF_BO40336 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrengements | 1 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangement_NTF | 2 |
| Recruitment arrangements (for publication) | K2_Additional Document_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1__BO40336_DEU_diagnostic_v1 | 1 |
| Subject information and informed consent form (for publication) | L1_Appendix 1 - GDPR | 1 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_ ICF Addendum v1_14022022 | 1 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_diagnostic_v4 | 4 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_ICF_MAIN_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_pregant Partnerin_v1 | 1 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_PregPatientForm V1 | 1 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_RBR_v1 | 1 |
| Subject information and informed consent form (for publication) | L1_BO40336_DEU_RBR_v2_clean | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Diagnostic Test | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF RBR | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_and_SIS_Main_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_ICF_Diagnostic | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Mandatory gen | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_PP | 2 |
| Subject information and informed consent form (for publication) | L1_PIS_Diagnostic | 2 |
| Subject information and informed consent form (for publication) | L1_PIS_Main_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_PIS_Mandatory gen | 3 |
| Subject information and informed consent form (for publication) | L1_PIS_PP | 2 |
| Subject information and informed consent form (for publication) | L1_PIS_RBR | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Main ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Covid-19 ICF Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Diagnostic | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Diagnostic | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Diagnostic Test | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 6 |
| 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 | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN Addendum v2_BO40336 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional RBR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 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 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy consent form other subject | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 2 |
| 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 tumour tissue for mutations | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Enfermeria a Domicilio | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pruebas diagnosticas | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Anexo al ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_General y RBR | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_EN | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RO | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mobile Nursing_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mobile Nursing_RO | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pareja embarazada | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Authorization Form_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Authorization Form_RO | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Biosample Repository_EN_clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Biosample Repository_RO | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sample Diagnostic Testing_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sample Diagnostic Testing_RO | 1 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Main_AT | 7.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_PPA_AT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_RBR_AT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Right to not know | 1 |
| Subject information and informed consent form (for publication) | L2_Subjects rights | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ALIMTA 500 mg powder for concentrate for solution for infusion.pdf | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin NeoCorp 1 mgml - Konzentrat zur Herstellung einer Infusionslosun.pdf | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabin-GRY 1000 mg Pulver zur Herstellung einer Infusionslosung.pdf | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC VINORELBINE.pdf | NA |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_at-de-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_gr-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-506861-76-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ro-2023-506861-76-00 | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-19 | Denmark | Acceptable 2024-05-21
|
2024-05-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-27 | Acceptable 2024-05-21
|
2024-08-27 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-30 | Denmark | Acceptable | 2024-12-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-23 | Denmark | Acceptable 2025-03-28
|
2025-03-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-22 | Acceptable | 2025-05-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-09 | Denmark | Acceptable 2026-02-20
|
2026-02-20 |