A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery

Start 20 Nov 2019 · End 26 Nov 2024 · Status Ended · 11 EU/EEA countries · 50 sites · Protocol CA209-73L

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ended

Participants planned 1,184

Countries 11

Sites 50

Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

To compare progression-free survival (PFS) for Arm A vs Arm C

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: 20 Nov 2019 → 26 Nov 2024
Decision date (initial): 2023-05-12
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2022-502886-71-00
EudraCT number: 2019-001222-98
WHO UTN: U1111-1229-7290
ClinicalTrials.gov: NCT04026412

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To compare progression-free survival (PFS) for Arm A vs Arm C

Secondary objectives 7

To compare OS for Arm A vs Arm C
To evaluate PFS and OS for Arm B vs Arm C and Arm A vs Arm B
To evaluate tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to BICR assessment
To evaluate PFS and tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging
To evaluate time to death or distant metastases (TTDM) for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging
To assess safety and tolerability of study treatments
To evaluate symptom deterioration for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B

Conditions and MedDRA coding

Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Version	Level	Code	Term	System organ class
21.1	PT	10029519	Non-small cell lung cancer stage III	100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification
Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Exclusion criteria 4

Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study treatment
Active infection requiring systemic therapy within 14 days prior to randomization
History of organ or tissue transplant that requires systemic use of immune suppressive agents.
Prior thoracic radiotherapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR)

Secondary endpoints 16

OS for Arm A vs Arm C
Overall Survival (OS) for Arm B and Arm C
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C
Overall Survival (OS) for Arm A and Arm B
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B
Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR)
Progression-free survival (PFS) by RECIST 1.1 per investigator assessment
Objective response rate (ORR) by RECIST 1.1 per investigator assessment
DoR by RECIST 1.1 per investigator assessment
TTR by RECIST 1.1 per investigator assessment
Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Proportion of participants without symptom deterioration based on NSCLC-SAQ

Investigational products

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

Test 3

Ipilimumab

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: 1 mg/kg milligram(s)/kilogram
Max total dose: 8.67 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Ipilimumab

PRD191357 · Product

Active substance: Ipilimumab
Other product name: MDX-010
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1 mg/kg milligram(s)/kilogram
Max total dose: 8.67 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

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: 7320 mg milligram(s)
Max treatment duration: 61 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 17

ETO-cell® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD1958704 · Product

Active substance: Etoposide
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 100 mg/m2 milligram(s)/square meter
Max total dose: 900 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CB01 — ETOPOSIDE
Marketing authorisation: 46052.00.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Etoposide

SUB07337MIG · Substance

Active substance: Etoposide
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 100 mg/m2 milligram(s)/square meter
Max total dose: 900 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Durvalumab

SUB176342 · Substance

Active substance: Durvalumab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 240 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

IMFINZI 50 mg/mL concentrate for solution for infusion.

PRD6651398 · Product

Active substance: Durvalumab
Substance synonyms: MEDI4736
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 240 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L01XC28 — -
Marketing authorisation: EU/1/18/1322/001
MA holder: ASTRAZENECA AB
MA country: EU
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: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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

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: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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

Paclitaxel

SUB09583MIG · Substance

Active substance: Paclitaxel
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
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: 18 Other
Max treatment duration: 9 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: 18 Other
Max treatment duration: 9 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

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: 18 Other
Max treatment duration: 9 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

Carboplatin

SUB06614MIG · Substance

Active substance: Carboplatin
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 Other
Max total dose: 18 Other
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Disodium

SUB03669MIG · Substance

Active substance: Pemetrexed Disodium
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 1500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
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: 1500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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

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: 80 mg/m2 milligram(s)/square meter
Max total dose: 240 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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
Substance synonyms: Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 80 mg/m2 milligram(s)/square meter
Max total dose: 240 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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

SUB07483MIG · Substance

Active substance: Cisplatin
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 80 mg/m2 milligram(s)/square meter
Max total dose: 240 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
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: 80 mg/m2 milligram(s)/square meter
Max total dose: 240 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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

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: GCT-SU

Public contact point

Organisation: Bristol Myers Squibb International Corporation
Contact name: GCT-SU

Third parties 16

Organisation	City, country	Duties
PPD Development LP ORG-100011560	Richmond, United States	Other
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other, Data management
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other
National Genetics Institute ORG-100039148	Los Angeles, United States	Other
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Data management
Icon Laboratories Inc. ORG-100037135	Farmingdale, United States	Other
Syngene International Limited ORG-100012176	Bengaluru, India	Other
Labcorp Central Laboratory Services S.a.r.l. ORG-100011524	Meyrin, Switzerland	Other
Biostorage Technologies GmbH ORG-100022621	Griesheim, Germany	Other
Azenta US Inc. ORG-100016263	Indianapolis, United States	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Other, Data management
Q2 Solutions ORL-000000243	West Lothian, United Kingdom	Other
QARC ORL-000000352	Lincoln, Rhode Island, United States	Other
Y-Prime, Inc. ORL-000000955	Malvern, PA, United States	Other
Guardant Health Inc. ORG-100042461	Redwood City, United States	Other

Locations

11 EU/EEA countries · 50 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ended	17	4
France	Ended	120	10
Germany	Ended	72	10
Greece	Ended	40	2
Ireland	Ended	25	2
Italy	Ended	28	2
Netherlands	Ended	17	4
Poland	Ended	23	3
Romania	Ended	48	5
Spain	Ended	83	7
Sweden	Ended	12	1
Rest of world Mexico, China, Japan, Singapore, Canada, Russian Federation, Switzerland, United States, United Kingdom, Argentina, Korea, Republic of, Brazil, Taiwan, Australia, Chile	—	699	—

Investigational sites

Belgium

4 sites · Ended

Cliniques Universitaires Saint-Luc

Service de pneumologie, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Universitair Ziekenhuis Gent

Longziekten, Corneel Heymanslaan 10, 9000, Gent

CHC MontLegia

Hemato-Oncologie, Boulev. De Patience Et Beajonc 2, 4000, Liege

UCL Mont-Godinne

Pneumologie, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir

France

10 sites · Ended

Institut Curie

Oncologie médicale, 26 Rue D Ulm, 75005, Paris

Centre Hospitalier Universitaire De Nantes

Oncologie médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain

Assistance Publique Hopitaux De Paris

Oncologie-radiothérapie, 4 Rue De La Chine, 75020, Paris

Centre Hospitalier Regional Universitaire De Tours

Service Pneumologie, 2 Allee Gaston Pages, 37100, Tours

Assistance Publique Hopitaux De Paris

Oncologie thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

Assistance Publique Hopitaux De Paris

Oncologie thoracique, 46 Rue Henri Huchard, 75877, Paris Cedex 18

Centre Leon Berard

Oncologie médicale, 28 Rue Laennec, 69008, Lyon

Centre De Cancerologie Du Grand Montpellier

Centre de Cancérologie, 25 Rue De Clementville, 34070, Montpellier

Centr Georges Francois Leclerc

Oncologie médicale, 1 Rue Professeur Marion, 21000, Dijon

Institut Bergonie

Oncologie médicale, 229 Cours De L Argonne, 33000, Bordeaux

Germany

10 sites · Ended

LungenClinic Grosshansdorf GmbH

Onkologie, Wöhrendamm 80, 22927, Großhansdorf

Lungenfachklinik Immenhausen

Pneumologische Onkologie, Robert Koch Strasse 3, 34376, Immenhausen

KEM I Evang. Kliniken Essen-Mitte gGmbH

Klinik für Internistische Onkologie & Hämatologie mit integrierter Palliativmedizin, Henricistraße 92, Huttrop, Essen

Thoraxklinik At University Of Heidelberg

Onkologie der Thoraxtumoren, Amalienstraße 5, Rohrbach, Heidelberg

SLK-Kliniken GmbH - Standort Fachklinik Löwenstein

Medizinische Klinik II Onkologie / Krebsheilkunde mit Palliativmedizin, Geißhölzle 62, 74245, Löwenstein

Robert-Bosch-Krankenhaus GmbH

Abteilung für Pneumologische Onkologie, Auerbachstraße 110, Bad Cannstatt, Stuttgart

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR

III. Medizinische Klinik und Poliklinik Hämatologie, Internistische Onkologie und Pneumologie, Langenbeckstraße 1, Oberstadt, Mainz

Klinikverbund Allgau gGmbH

Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin, Robert Weixler Strasse 50, 87439, Kempten (Allgau)

Evangelisches Krankenhaus Hamm gGmbH

Klinik für Hämatologie, Onkologie und Pneumologie, Werler Strasse 110, Mitte, Hamm

Helios Klinikum Emil Von Behring GmbH

Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin

Greece

2 sites · Ended

Thoracic General Hospital Of Athens I Sotiria

3rd University Internal Medicine Oncology Unit, Messogion Avenue 152, 115 27, Athens

General University Hospital Of Larissa

Oncology Unit, P. O. Box 1425, 411 10, Larissa

Ireland

2 sites · Ended

St James's Hospital

Department of Oncology-Haematology, James's Street, Ireland, Dublin 8

St Vincent's University Hospital

Department of Medical Oncology, Nutley Lane, Elm Park, Dublin 4

Italy

2 sites · Ended

Fondazione IRCCS San Gerardo Dei Tintori

Oncologia, Via Giovanni Battista Pergolesi 33, 20900, Monza

University Hospital Of Perugia

UO Oncologia Medica, Via Gerardo Dottori 1, 06132, Perugia

Netherlands

4 sites · Ended

Stichting VUmc

Pulmonary Medicine, De Boelelaan 1117, 1081 HV, Amsterdam

University Hospital Maastricht

Department of Respiratory Medicine, P Debyelaan 25, 6229 HX, Maastricht

Maxima Medisch Centrum

Longgeneeskunde, De Run 4600, 5504 DB, Veldhoven

Stichting Rijnstate Ziekenhuis

Longgeneeskunde (longziekten), Wagnerlaan 55, 6815 AD, Arnhem

Poland

3 sites · Ended

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

Provita Centrum Medyczne Sp. z o.o.

N/A, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki

Romania

5 sites · Ended

Focus Lab Plus S.R.L.

Medical Oncology, Strada Ciresului Nr. 1, 024103, Bucharest

Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca

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

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

Centrul De Oncologie Sf Nectarie S.R.L.

Medical Oncology, Strada Caracal Nr. 109, 200746, Craiova

Spain

7 sites · Ended

Complexo Hospitalario Universitario De Santiago

Servicio de Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela

University Hospital Virgen Del Rocio S.L.

Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital General Universitario Gregorio Maranon

Oncologia, Calle Del Doctor Esquerdo 46, 28009, Madrid

Hospital Universitario La Paz

Servicio de Oncologia, Paseo Castellana 261, 28046, Madrid

Bellvitge University Hospital

Oncologia, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat

Hospital Clinico Universitario Lozano Blesa

Oncologia, Avenida De San Juan Bosco 15, 50009, Zaragoza

Hospital De La Santa Creu I Sant Pau

Servicio Oncologia Medica, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Sweden

1 site · Ended

Sahlgrenska University Hospital-Vastra Gotalandsregionen

Department of Oncology/Blå stråket 2, 413 45 Göteborg, Bla Straket 5, 413 46, Goteborg

Country notifications

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

Country	Trial start	Recruitment start	Recruitment end
Belgium	2019-12-09	2020-06-17	2022-09-27
France	2019-12-13	2019-12-16	2022-09-30
Germany	2019-12-23	2019-12-23	2022-09-30
Greece	2020-08-31	2020-11-11
Ireland	2020-12-16	2021-01-28	2022-04-25
Italy	2020-02-03	2020-10-19	2022-10-04
Netherlands	2020-10-06	2021-02-23	2022-03-01
Poland	2019-11-20	2019-12-20	2022-10-04
Romania	2020-07-02	2020-07-08	2022-10-04
Spain	2019-12-23	2020-01-31	2022-09-30
Sweden	2019-12-20	2020-03-24	2022-10-04

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
2022-502886-71-00_Summary of Results SUM-75034	2025-03-17T10:07:03	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
2022-502886-71-00_Lay Person Summary of Results_ES	2025-12-02T09:58:12	Submitted	Laypersons Summary of Results
2022-502886-71-00_ Lay Person Summary of Results	2025-10-23T09:29:19	Submitted	Laypersons Summary of Results
2022-502886-71-00_ Lay Person Summary of Results_IT	2025-10-30T16:01:52	Submitted	Laypersons Summary of Results
2022-502886-71-00_Lay Person Summary of Results_FR	2025-11-04T10:40:57	Submitted	Laypersons Summary of Results
2022-502886-71-00_ Lay Person Summary of Results_DE	2025-10-31T09:50:44	Submitted	Laypersons Summary of Results
2022-502886-71-00_ Lay Person Summary of Results_PL	2025-10-31T08:42:14	Submitted	Laypersons Summary of Results

Documents 11 files

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

Type	Title	Version
Laypersons summary of results (for publication)	2022-502866-71-00_Lay Person Summary of Results_ES	1
Laypersons summary of results (for publication)	2022-502886-71-00_ Lay Person Summary of Results	N/A
Laypersons summary of results (for publication)	2022-502886-71-00_ Lay Person Summary of Results_DEU	N/A
Laypersons summary of results (for publication)	2022-502886-71-00_ Lay Person Summary of Results_IT	1
Laypersons summary of results (for publication)	2022-502886-71-00_ Lay Person Summary of Results_PL	1
Laypersons summary of results (for publication)	2022-502886-71-00_Lay Person Summary of Results_FR	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements_IE	V2
Subject information and informed consent form (for publication)	L1_ SIS and ICF_IE_Main_ENG_redacted	7.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_IE_Retreatment_ENG_redacted	2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_IE_Treatment Beyond Progression addendum_ENG	2.0
Summary of results (for publication)	2022-502886-71-00_Summary of Results	2

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-03-02	Netherlands	Acceptable 2023-04-11	2023-04-11
2	SUBSTANTIAL MODIFICATION	SM-3	2023-12-20	Netherlands	Acceptable 2024-03-06	2024-03-06
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-05-20	Netherlands	Acceptable 2024-03-06	2024-05-20
4	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-02-11		Acceptable 2024-03-06	2026-02-11

A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 7

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 3

Exclusion criteria 4

Endpoints

Primary endpoints 1

Secondary endpoints 16

Investigational products

Test 3

Comparator 17

Sponsors and contacts

Bristol Myers Squibb International Corporation

Scientific contact point

Public contact point

Third parties 16

Locations

By country

Investigational sites

Country notifications

Results and documents

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 11 files

Application history

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