A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.

Start 22 Sep 2019 · Status Ongoing, recruitment ended · 9 EU/EEA countries · 35 sites · Protocol CA209-77T

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 750

Countries 9

Sites 35

Resectable Stage II-IIIB Non-small cell lung cancer

To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A vs Arm B participants

Key facts

Sponsor: Bristol-Myers Squibb Services Unlimited Company
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 22 Sep 2019 → ongoing
Decision date (initial): 2023-07-27
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Bristol-Myers Squibb International Corporation

External identifiers

EU CT number: 2022-502658-15-00
EudraCT number: 2019-000262-38
WHO UTN: U1111-1226-5321
ClinicalTrials.gov: NCT04025879

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic, Safety, Efficacy, Therapy, Pharmacokinetic, Others, Pharmacodynamic, Pharmacogenomic

To compare the event-free survival (EFS) by blinded independent central
review (BICR) in Arm A vs Arm B participants

Secondary objectives 4

To compare the overall survival (OS) in Arm A vs Arm B participants
To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants
To assess the major pathological response (MPR) rate by BIPR in Arm A vs Arm B participants
To assess safety and tolerability in Arm A vs Arm B participants

Conditions and MedDRA coding

Resectable Stage II-IIIB Non-small cell lung cancer

Version	Level	Code	Term	System organ class
21.1	PT	10061873	Non-small cell lung cancer	100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
No brain metastasis
Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
Ability to provide surgical or biopsy tumor tissue for biomarkers
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion criteria 4

Participants with an active, known or suspected autoimmune disease
Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co stimulation or checkpoint pathways

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)

Secondary endpoints 5

Overall Survival (OS)
Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
Incidence of Serious Adverse Events (SAEs)
Incidence of Adverse Events (AEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD2941375 · Product

Active substance: Nivolumab
Substance synonyms: BMS936558
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 480 mg milligram(s)
Max total dose: 7680 mg milligram(s)
Max treatment duration: 64 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

Comparator 13

Bendatax 6 mg/ ml

PRD2957674 · Product

Active substance: Paclitaxel
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/square meter
Max total dose: 800 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01CD01 — PACLITAXEL
Marketing authorisation: 69664.00.00
MA holder: BENDALIS GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

TAXOL 6 mg/ml, concentrato per soluzione per infusione.

PRD9946309 · Product

Active substance: Paclitaxel
Substance synonyms: ONCOGEL, ABI-007, MBT 0206
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/square meter
Max total dose: 800 mg/m2 milligram(s)/square meter
Max treatment duration: 12 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: No

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: 200 mg/m2 milligram(s)/square meter
Max total dose: 800 mg/m2 milligram(s)/square meter
Max treatment duration: 12 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: No

Paclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD9974697 · Product

Active substance: Paclitaxel
Substance synonyms: ONCOGEL, ABI-007, MBT 0206
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/square meter
Max total dose: 800 mg/m2 milligram(s)/square meter
Max treatment duration: 12 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: No

CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung Carboplatin

PRD1969079 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 Other
Max total dose: 24 Other
Max treatment duration: 12 Week(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: No

Carbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD536350 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 Other
Max total dose: 24 Other
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 39079.02.00
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung

PRD2832939 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 Other
Max total dose: 24 Other
Max treatment duration: 12 Week(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: No

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: INTRAVENOUS USE
Max daily dose: 75 mg/m2 milligram(s)/square meter
Max total dose: 300 mg/m2 milligram(s)/square meter
Max treatment duration: 12 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: No

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: 75 mg/m2 milligram(s)/square meter
Max total dose: 300 mg/m2 milligram(s)/square meter
Max treatment duration: 12 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: No

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: 75 mg/m2 milligram(s)/sq. meter
Max total dose: 300 mg/m2 milligram(s)/sq. meter
Max treatment duration: 12 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: No

Doce NC 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD783819 · Product

Active substance: Docetaxel
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 75 mg/m2 milligram(s)/square meter
Max total dose: 300 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01CD02 — DOCETAXEL
Marketing authorisation: 79736.00.00
MA holder: HEXAL AG
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Docetaxel-Ebewe, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji

PRD761645 · Product

Active substance: Docetaxel
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 75 mg/m2 milligram(s)/square meter
Max total dose: 300 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01CD02 — DOCETAXEL
Marketing authorisation: 16652
MA holder: EBEWE PHARMA
MA country: Poland
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: INTRAVENOUS USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 2000 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(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

Placebo 2

5% Dextrose Solution for Injection

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

0.9% Sodium Chloride Solution for Injection

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation: Bristol-Myers Squibb Services Unlimited Company
Address: Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
City: Dublin 15
Postcode: D15 T867
Country: Ireland

Scientific contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Public contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Third parties 22

Organisation	City, country	Duties
Q2 Solutions ORL-000001988	United States	Other
Smithers PDS LLC ORG-100040403	Gaithersburg, United States	Other
Smithers PDS LLC ORG-100040403	Gaithersburg, United States	Other
Azenta US Inc. ORG-100016263	Indianapolis, United States	Other
Q2 Solutions ORL-000010694	Valencia, United States	Other
Icon Laboratories Inc. ORG-100037135	Farmingdale, United States	Other
Accenture Services Pvt. Ltd. ORL-000000127	Bengaluru, India	Other
Clario ORL-000001208	Princeton, United States	Other
Personalis Inc. ORG-100043141	Fremont, United States	Other
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
Mosaic Laboratories LLC ORG-100042385	Lake Forest, United States	Other
Azenta Singapore Pte Ltd ORG-100049467	Singapore, Singapore	Other
Azenta Germany GmbH ORG-100039257	Griesheim, Germany	Other
Johns Hopkins University School of Medicine, Division of Kidney-Urologic Pathology ORL-000000136	Baltimore, United States	Other
Syneos Health Inc. ORG-100008382	Morrisville, United States	On site monitoring, Code 10, Code 11, Code 12, Code 2, Data management, Code 8, Code 9
Parexel International ORL-000007312	Billerica/MA, United States	Other
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other, Interactive response technologies (IRT)
Labcorp \| Center for Molecular Biology and Pathology ORL-000005147	Durham, United States	Other
Axio ORL-000007233	Seattle, United States	Other
Q2 Solutions ORL-000000131	Livingston, United Kingdom	Other
Q Squared Solutions Holdings LLC ORG-100043288	Durham, United States	Other
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other, Data management

Locations

9 EU/EEA countries · 35 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruitment ended	20	3
Czechia	Ongoing, recruitment ended	13	2
France	Ongoing, recruitment ended	50	5
Germany	Ongoing, recruitment ended	70	11
Italy	Ongoing, recruitment ended	20	3
Netherlands	Ongoing, recruitment ended	13	2
Poland	Ongoing, recruitment ended	19	1
Romania	Ongoing, recruitment ended	20	3
Spain	Ongoing, recruitment ended	27	5
Rest of world Australia, Taiwan, China, Argentina, Brazil, Mexico, United States, Japan	—	498	—

Investigational sites

Belgium

3 sites · Ongoing, recruitment ended

Antwerp University Hospital

Oncology, Drie Eikenstraat 655, 2650, Edegem

CHC MontLegia

Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege

Az Delta

Oncology, Deltalaan 1, 8800, Roeselare

Czechia

2 sites · Ongoing, recruitment ended

Vseobecna Fakultni Nemocnice V Praze

Onkologicka klinika VFN a 1. LF UK, U Nemocnice 499/2, Nove Mesto, Prague

Fakultni Thomayerova Nemocnice

Pneumologicka klinika 1. LF UK a TN, Videnska 800, Krc, Prague 4

France

5 sites · Ongoing, recruitment ended

Centre Hospitalier Universitaire Grenoble Alpes

Pôle Thorax et Vaisseaux-Service de Pneumonologie, Oncologie-thoracique, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9

CHU De Rouen

Service de Pneumonologie, Oncologie-thoracique et Soins intensifs respiratoires, 1 Rue De Germont, Bp 96031, Rouen Cedex

Assistance Publique Hopitaux De Paris

Service de Pneumonologie, 4 Rue De La Chine, 75020, Paris

University Hospital Of Montpellier

Service des maladies respiratoires-Unité d'oncologie thoracique, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Rennes

Service de Pneumonologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9

Germany

11 sites · Ongoing, recruitment ended

Kliniken der Stadt Koeln gGmbH

Lungenklinik Merheim Studienzentrum der Thoraxchirugischen Klinik, Ostmerheimer Strasse 200, Merheim, Cologne

Thoraxklinik At University Of Heidelberg

Thoraxonkologisches Studienzentrum, Amalienstrasse 5, Rohrbach, Heidelberg

Krankenhaus Nordwest GmbH

Onkologie und Haematologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main

Klinik Loewenstein gGmbH

Medizinische Klinik II Onkologie, Geisshölzle 62, 74245, Loewenstein

Krankenhaus Bethanien

Lungenzentrum, Bethanienstr. 21, 47441, Moers

Klinikverbund Allgau gGmbH

Klinik Immenstadt, Klinik fuer Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin, Im Stillen 2, 87509, Immenstadt I. Allgäu

Evangelisches Krankenhaus Hamm gGmbH

Klinik fuer Haematologie, Onkologie und Pneumologie, Werler Strasse 110, Mitte, Hamm

Charite Universitatsmedizin Berlin KöR

Klinik fuer Infektiologie & Pneumologie, Campus Virchow Klinikum, Augustenburger Platz 1, Wedding, Berlin

Franziskus Hospital Harderberg

Zentrum fuer Haematologie und Onkologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette

University Medical Centre Schleswig-Holstein

Medizinische Klinik III - Pulmologie, Ratzeburger Allee 160, 23538, Lübeck

RKH Klinken Ludwigsburg-Bietigheim gGmbH

Abteilung Haematoonkologie, Posilipostrasse 4, Mitte, Ludwigsburg

Italy

3 sites · Ongoing, recruitment ended

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Medical oncology, Via Francesco Sforza 28, 20122, Milan

Azienda Ospedaliero Universitaria Parma

Medical oncology, Viale Antonio Gramsci 14, 43126, Parma

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori S.r.l.

Medical oncology, Via Piero Maroncelli 40, 47014, Meldola

Netherlands

2 sites · Ongoing, recruitment ended

University Medical Center Groningen

Pulmonary department, Hanzeplein 1, 9713 GZ, Groningen

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Pulmonary medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Poland

1 site · Ongoing, recruitment ended

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Oddział Kliniczny Chirurgii Klatki Piersiowej i Chirurgii Onkologicznej, ul. Prądnicka 80, 31-202, Kraków

Romania

3 sites · Ongoing, recruitment ended

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest

Radiotherapy Center Cluj S.R.L.

Medical Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti

Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca

Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca

Spain

5 sites · Ongoing, recruitment ended

Hospital Universitario Puerta De Hierro De Majadahonda

Servicio Oncologia Medica, Calle De Manuel De Falla 1, 28222, Majadahonda

Catalan Institute Of Oncology

Servicio de Oncologia, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Hospital Universitario De La Princesa

Servicio de Oncologia Medica, Calle De Diego De Leon 62, 28006, Madrid

Hospital Universitario Y Politecnico La Fe

Servicio de Oncologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Universitari Vall D Hebron

Oncologia Medica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start	Recruitment end
Belgium	2019-12-11	2020-09-29	2022-02-24
Czechia	2019-11-19	2019-11-26	2022-02-21
France	2019-12-23	2020-01-23	2022-02-25
Germany	2020-01-23	2020-02-07	2022-02-28
Italy	2020-10-15	2020-11-06	2022-02-28
Netherlands	2019-12-11	2020-02-07	2021-12-03
Poland	2019-09-22	2019-11-21	2022-02-24
Romania	2020-06-26	2020-06-26	2022-02-28
Spain	2019-12-05	2020-02-13	2022-02-28

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 121 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Clinical study report (for publication)	2022-502658-15-00_ ca20977t-primary-csr-14-3-3-narratives-euctr	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-14-figures	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-14-tables	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-16-1-1-protocol-info	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-16-1-2-sam-crf	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-16-1-9-stat-info	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-report-body	1
Clinical study report (for publication)	2022-502658-15-00_ca20977t-primary-csr-synopsis	1
Protocol (for publication)	D1_Protocol 2022-502658-15-00_redacted	2
Protocol (for publication)	D1_Protocol Administrative Letter 2022-502658-15-00_redacted	N/A
Protocol (for publication)	D4 Questionnaire - redacted placeholder_GER_D	1
Protocol (for publication)	D4 statement on validated questionnaires under licence_BE	NA
Protocol (for publication)	D4 statement on validated questionnaires under licence_CZ	NA
Protocol (for publication)	D4 statement on validated questionnaires under licence_PL	NA
Protocol (for publication)	D4_IT_Questionnaire redacted placeholder	1
Protocol (for publication)	D4_Patient facing documents_Questionnaire EQ-5D-3L_FR_Statement	1
Protocol (for publication)	D4_Patient facing documents_Questionnaire FACT-L_FR_Statement	1
Protocol (for publication)	D4_Patient facing documents_Questionnaire NSCLC-SAQ_FR_Statement	1
Protocol (for publication)	D4_Patient facing documents_Questionnaire PGIS_FR_Statement	1
Protocol (for publication)	D4_Patient facing documents_Questionnaire PROMIS_FR_Statement	1
Protocol (for publication)	D4_Patient facing documents_statement for licensed questionnaires	1
Protocol (for publication)	D4_Statement on validated questionnaires under licence_RO	1
Protocol (for publication)	D4_Statement on validated questionnaires under license_NL	NA
Protocol (for publication)	D4_Statement on validated questionnaires under license_NL	NA
Recruitment arrangements (for publication)	BE K59 RECRUITMENT PROCEDURE_sanitised	NA
Recruitment arrangements (for publication)	Blank document_recruitment arrangements	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements _blank document for transition	1
Recruitment arrangements (for publication)	K1_blank document_recruitment arrangements_NL	NA
Recruitment arrangements (for publication)	K1_Recruitment arrangement_blank statement_IT	NA
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_blank document_GER	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_CZ	N/A
Recruitment arrangements (for publication)	K1_Recruitment arrangements_ES	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_FR	1.0
Recruitment arrangements (for publication)	K1_Recruitment material_Study Connect Leaflet_CZ	N/A
Subject information and informed consent form (for publication)	221007_CA209-77T_ICF_Main_V7_220920_D_GER_global_V10_appr_redacted	7
Subject information and informed consent form (for publication)	221118_CA209-77T_Add-Main_V07_221102_D_GER_Global_V8_appr_redacted	7
Subject information and informed consent form (for publication)	BE L61 SIS CF Addendum to main_Dutch_sanitised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Addendum to main_English_santised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Addendum to main_French_sanitised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Addendum to main_German_santised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Main_Dutch_v7_dd 09Sep21_Redacted	7
Subject information and informed consent form (for publication)	BE L61 SIS CF Main_English_v7_dd 09Sep21_Redacted	7
Subject information and informed consent form (for publication)	BE L61 SIS CF Main_French_v7_dd 09Sep21_Redacted	7
Subject information and informed consent form (for publication)	BE L61 SIS CF Main_German_v7_dd 09Sep21_Redacted	7
Subject information and informed consent form (for publication)	BE L61 SIS CF Pregnant partner_Dutch_sanitised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Pregnant partner_English_sanitised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Pregnant partner_French_sanitised	2
Subject information and informed consent form (for publication)	BE L61 SIS CF Pregnant partner_German_sanitised	2
Subject information and informed consent form (for publication)	BE L62 INFORMED CONSENT PROCEDURE_sanitized	1
Subject information and informed consent form (for publication)	CA209-77T ITA Addendum 5 v 1 del 19Ottobre 2022 Clean	5
Subject information and informed consent form (for publication)	CA209-77T ITA ICF Main v 5 del 31Aug2021 clean Redacted	1
Subject information and informed consent form (for publication)	CA209-77T ITA_ICF Addendum 6 del 26 Marzo 2024_clean	6
Subject information and informed consent form (for publication)	CA209-77T ITA_ICF Addendum 6 del 26 Marzo 2024_TC	6
Subject information and informed consent form (for publication)	L1_ SIS and ICF addendum	7.0
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 ICF no redaction	7.1
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main_Redacted	1
Subject information and informed consent form (for publication)	L1_ SIS and Pregnant Partner ICF	1
Subject information and informed consent form (for publication)	L1_ICF Addendum	8
Subject information and informed consent form (for publication)	L1_Informed consent procedure_FR_Redacted	1
Subject information and informed consent form (for publication)	L1_Main ICF_version 7_8Sep2021_ES_Redacted	7
Subject information and informed consent form (for publication)	L1_SIS and ICF Add Main_V08_DE_GER	8
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 07_FR	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 1_CZ_Redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF addendum 2 to main IC BE ENG	1
Subject information and informed consent form (for publication)	L1_SIS and ICF addendum 2 to main IC BE FRE	1
Subject information and informed consent form (for publication)	L1_SIS and ICF addendum 2 to main IC BE NLD	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 2_CZ_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 3_CZ	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 4_CZ_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 5_CZ_Redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 6_CZ	6.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum 7_CZ	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum for Nivo IB 21_santised_NL	NA
Subject information and informed consent form (for publication)	L1_SIS and ICF addendum_NL	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF addendum_NL_TC	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Data privacy_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Greenphire Direct Deposit	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_CZ_Redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_NL_Redacted	9
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Biopsy_CZ_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Biopsy_TC_CZ	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Patient Letter_NL_Redacted	1
Subject information and informed consent form (for publication)	L2_ Other subject information material_subject alert card_Redacted	1
Subject information and informed consent form (for publication)	L2_Other subject information material_CN_CZ	3.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CN_TC_CZ	3.0
Subject information and informed consent form (for publication)	L2_Patient Notification letter	1
Subject information and informed consent form (for publication)	L3_Pregnant Partner ICF v2_21Jan2020_ES	2
Subject information and informed consent form (for publication)	M1_SIS and ICF Addendum 05_FR_Redacted	1.0
Subject information and informed consent form (for publication)	M1_SIS and ICF Addendum 06_FR_Redacted	1.0
Subject information and informed consent form (for publication)	M1_SIS and ICF Main_FR_Redacted	6.0
Subject information and informed consent form (for publication)	M1_SIS and ICF Optionnal 01_FR_Redacted	1.0
Subject information and informed consent form (for publication)	M1_SIS and ICF Optionnal 01_Not used PA03_FR_Redacted	2.0
Subject information and informed consent form (for publication)	M1_SIS and ICF Pregnant partner_FR	1.0
Summary of Product Characteristics (SmPC) (for publication)	alimta-epar-summary of changes	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1 SmPC_Carboplatin Accord-UK 21-Aug-2024 vs 19-Jul-2024-highlighted changes	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC ALIMTA pemetrexed Lilly _ TC	28
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC ALIMTA pemetrexed Lilly RSI EMA	28
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Carboplatin Accord RSI UK	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Cisplatin Teva RSI UK	6
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC TAXOL Cheplapharm paclitaxel BMS RSI IT	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC TAXOL Cheplapharm paclitaxel BMS RSI IT_highlighted changes	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC TAXOTERE docetaxel Sanofi RSI EMA	47
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC_Carboplatin Accord-UK 09-Jun-2023 vs Oct-2022-highlighted changes	N/A
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_DE 2022-502658-15-00_redacted	1
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_PL 2022-502658-15-00_PL	1
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_PL 2022-502658-15-00_Redacted	NA
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_RO 2022-502658-15-00_RO	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis BE_2022-502658-15_DEU	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis BE_2022-502658-15_FR	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis BE_2022-502658-15_NLD	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL_2022-502658-15_NLD	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ IT 2022-502658-15_IT	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2022-502658-15-00_01	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_CZ_2022-502658-15-00_Redacted	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_ES 2022-502658-15-00_ES	1
Synopsis of the protocol (for publication)	D1_protocol synopsis_EU CT 2022-502658-15-00_BE	NA
Synopsis of the protocol (for publication)	D1_protocol synopsis_EU CT 2022-502658-15-00_IT_Redacted	1
Synopsis of the protocol (for publication)	D1_protocol synopsis_EU CT 2022-502658-15-00_NL	NA
Synopsis of the protocol (for publication)	D1_Protocol synopsis_FR 2022-502658-15-00_FR	1

Application history

10 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-03-31	Spain	Acceptable 2023-07-24	2023-07-24
2	SUBSTANTIAL MODIFICATION	SM-2	2023-08-07	Spain	Acceptable 2023-10-03	2023-10-03
3	SUBSTANTIAL MODIFICATION	SM-3	2024-05-24	Spain	Acceptable 2024-07-16	2024-07-18
4	SUBSTANTIAL MODIFICATION	SM-4	2024-09-20	Spain	Acceptable 2024-11-12	2024-11-12
5	SUBSTANTIAL MODIFICATION	SM-5	2024-12-20	Spain	Acceptable 2025-04-11	2025-04-11
6	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-04-22		Acceptable 2025-04-11	2025-04-22
7	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-04-23		Acceptable 2025-04-11	2025-04-23
8	SUBSTANTIAL MODIFICATION	SM-6	2025-04-30	Spain	Acceptable 2025-05-27	2025-05-27
9	SUBSTANTIAL MODIFICATION	SM-7	2025-06-30	Spain	Acceptable 2025-09-25	2025-09-26
10	SUBSTANTIAL MODIFICATION	SM-8	2025-11-28	Spain	Acceptable 2026-02-16	2026-02-16

A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 4

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 5

Exclusion criteria 4

Endpoints

Primary endpoints 1

Secondary endpoints 5

Investigational products

Test 1

Comparator 13

Placebo 2

Sponsors and contacts

Bristol-Myers Squibb Services Unlimited Company

Scientific contact point

Public contact point

Third parties 22

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 121 files

Application history

Related clinical trials