Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
840
Countries
7
Sites
22
Stage IV Non-Small Cell Lung Cancer (NSCLC)
To compare the efficacy of nivolumab + ipilimumab with chemotherapy vs chemotherapy in participants with histologically Confirmed stage IV NSCLC
Key facts
- Sponsor
- Bristol Myers Squibb International Corporation
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Sep 2017 → 19 Oct 2024
- Decision date (initial)
- 2024-03-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508757-75-00
- EudraCT number
- 2017-001195-35
- WHO UTN
- U1111-1194-5135
- ClinicalTrials.gov
- NCT03215706
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To compare the efficacy of nivolumab + ipilimumab with chemotherapy vs chemotherapy in participants with histologically Confirmed stage IV NSCLC
Secondary objectives 3
- To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy in participants with histologically confirmed stage IV NSCLC
- To evaluate efficacy outcomes in participants with histologically confirmed stage IV NSCLC treated with nivolumab + ipilimumab combined with chemotherapy vs chemotherapy with different PDL1 expression levels
- To evaluate tumor mutation burden as a potential predictive biomarker of efficacy (such as ORR, PFS and OS) of nivolumab + ipilimumab in combination with chemotherapy using DNA derived from tumor and blood (germline) specimens
Conditions and MedDRA coding
Stage IV Non-Small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test [minimum sensitivity 25 units per litre (IU/L) or equivalent units of human chorionic gonadotropin (HCG)] within 24 hours prior to the start of study drug
- WOCBP must agree to follow instructions for methods(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of nivolumab (ie 30 days [duration of ovulatory cycle] plus the time required for nivolumab to undergo approximately five half-lives)
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and up to 7 months after the last dose of nivolumab (ie 90 days [duration of sperm turnover] plus the time required for nivolumab to undergo approximately five half-lives)
Exclusion criteria 3
- Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
- Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
- Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall Survival (OS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy
Secondary endpoints 9
- Progression Free Survival (PFS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
- Overall Response Rate (ORR): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
- ORR: In participants with different PD-L1 levels
- PFS: In participants with different PD-L1 levels
- OS: In participants with different PD-L1 levels
- ORR: In association with tumor cell total somatic mutation numbers
- PFS: In association with tumor cell total somatic mutation numbers
- OS: In association with tumor cell total somatic mutation numbers
- Blood TMB analysis
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD191358 · Product
- Active substance
- Ipilimumab
- Other product name
- MDX-010
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/kg milligram(s)/kilogram
- Max total dose
- 9999 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 8
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(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
- clinical label for the purpose of this trial
Cisplatin-Ebewe, 1 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji
PRD771236 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(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
- clinical label for the purpose of this trial
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD662245 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(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
- clinical label for the purpose of this trial
TAXOL 6 mg/ml, concentrato per soluzione per infusione.
PRD9946309 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 028848024
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Paclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9974697 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 67896.00.00
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Paclitaxel-GRY® 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD718972 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 62763.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD291536 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical overlabeling for the purpose of this trial
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Biostorage Technologies Inc. ORG-100013143
|
Indianapolis, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Syngene International Limited ORG-100012176
|
Bangalore, India | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Data management, E-data capture |
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other |
| Laboratory Corporation Of America Holdings ORG-100041800
|
Los Angeles, United States | Other |
Locations
7 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 11 | 1 |
| France | Ended | 48 | 6 |
| Germany | Ended | 30 | 5 |
| Ireland | Ended | 7 | 1 |
| Poland | Ended | 80 | 2 |
| Romania | Ended | 150 | 2 |
| Spain | Ended | 130 | 5 |
| Rest of world
Canada, Chile, United Kingdom, Mexico, United States, Brazil, Argentina, Australia
|
— | 384 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Pulmonary Physician and Thoracic Oncologist, Deltalaan 1, 8800, Roeselare
Centre Hospitalier Universitaire De Caen Normandie
Service de Pneumologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Leon Berard
Service Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Nantes
Service Oncologie Médicale Thoracique et Digestive, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Montpellier
Departement Pneumologie et Addictologie, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Lyon Sud
Service Pneumo-Oncologie, Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Lille
Service de pneumologie et oncologie thoracique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
HELIOS Klinikum Emil von Behring GmbH
Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Asklepios Fachkliniken Muenchen Gauting
Klinik für Pneumologie, Robert-Koch-Allee 2, 82131, Gauting
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Robert-Bosch-Krankenhaus GmbH
Abteilung für Pneumologische Onkologie, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Zentrum für Pneumologie und Thoraxchirurgie, Theo-Funccius-Strasse 1, 58675, Hemer
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya 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 | 2017-12-22 | 2024-10-17 | 2018-02-14 | 2018-11-26 | |
| France | 2017-11-09 | 2024-10-16 | 2017-11-20 | 2018-11-26 | |
| Germany | 2017-11-13 | 2024-10-18 | 2017-12-01 | 2018-11-26 | |
| Ireland | 2018-01-16 | 2024-10-07 | 2018-02-01 | ||
| Poland | 2018-01-26 | 2024-10-18 | 2018-01-29 | 2018-11-26 | |
| Romania | 2018-05-24 | 2024-10-18 | 2018-05-25 | 2018-11-26 | |
| Spain | 2017-09-18 | 2024-10-17 | 2017-09-28 | 2018-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508757-75-00_Final Summary of Results SUM-102516
|
2025-10-17T09:03:58 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508757-75-00_Lay Person Summary of Results | 2025-10-01T11:09:25 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_Spanish | 2025-10-07T11:35:03 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_French | 2025-10-07T16:15:31 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_Romanian | 2025-10-08T10:52:35 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_German | 2025-10-10T08:51:10 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_Polish | 2025-10-10T11:33:43 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_Dutch_BE | 2025-10-14T23:58:09 | Submitted | Laypersons Summary of Results |
| 2023-508757-75-00_Lay Person Summary of Results_French_BE | 2025-10-14T23:59:59 | Submitted | Laypersons Summary of Results |
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results | N/A |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_Dutch_BE | Final |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_French | NA |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_French_BE | Final |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_German | N/A |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_Polish | N/A |
| Laypersons summary of results (for publication) | 2023-508757-75-00_Lay Person Summary of Results_Romanian | NA |
| Laypersons summary of results (for publication) | CA209-9LA-PLS_ES | 1 |
| Protocol (for publication) | D1_Protocol_2023-508757-75-00_Redacted | 5 |
| Recruitment arrangements (for publication) | K_Statement for Recruitment and Informed Consent Procedures Form_PL | N/A |
| Recruitment arrangements (for publication) | K1_BE_Blank statement_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_IE_Blank statement_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_RO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank statement_FR | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_statement_DE | 1 |
| Subject information and informed consent form (for publication) | L SIS and ICF addendum _redacted _PL | 4 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 01_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 02_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 03_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 04_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 05_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 06_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 07_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Addendum 08_FR | 1.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Additionnal ICF 01_Ttm Beyond Progression_FR | 2.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Additionnal ICF 02_Optional Sample Collection_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_Main ICF_FR_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L_ICF and SIS_NI Complementaire 01_Patient LTFU_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum GDPR_en_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum GDPR_fr_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum GDPR_nl_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_en | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_fr | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum_Nivo IB19_en | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum_Nivo IB19_fr | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF Addendum_Nivo IB19_nl | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_nl | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_optional tumour biopsy_en_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_optional tumour biopsy_fr_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_ICF addendum_optional tumour biopsy_nl_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_Main IC_fr_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_BE_Main ICF_en_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_BE_Main ICF_nl_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_BE_Treatment Beyond Progression ICF_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_Treatment Beyond Progression ICF_fr | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_Treatment Beyond Progression ICF_nl | 2.0 |
| Subject information and informed consent form (for publication) | L1_IE_ICF Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_ICF Addendum_Optional Biopsy upon progression_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_ICF Addendum_Treatment Beyond Progression | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_ICF Addendum. | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_ICF Addendum.. | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Patient reimbursement_PL Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum _PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_ES | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy_ PL Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Add_ PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_ PL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 4.0 |
| 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 Biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Tumor Biopsy _ES_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 Pregnant Partner_ES | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_ES | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ addendum Optional Biopsy_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_2 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_3 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_4 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_5 | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AddResearch_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main _redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OTB_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed | 1 |
| Summary of results (for publication) | 2023-508757-75-00_Final Summary of Results | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis EU CT _2023-508757-75_PL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508757-75-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2023-508757-75-00_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_EU CT 2023-508757-75 | 1 |
| Synopsis of the protocol (for publication) | Synopsis_EU CT _2023-508757-75_German_BE | 1 |
| Synopsis of the protocol (for publication) | Synopsis_EU CT_2023-508757-75_Dutch_BE | 1 |
| Synopsis of the protocol (for publication) | Synopsis_EU CT_2023-508757-75_French_BE | 1 |
| Synopsis of the protocol (for publication) | Synopsis_EU CT_2023-508757-75_Spanish_ES | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-26 | Spain | Acceptable 2024-03-01
|
2024-03-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-09 | Spain | Acceptable 2024-09-11
|
2024-09-11 |