A Neoadjuvant Study of Nivolumab plus Ipilimumab or Nivolumab plus Chemotherapy versus Chemotherapy alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Start 15 Mar 2017 · End 13 Dec 2024 · Status Ended · 4 EU/EEA countries · 16 sites · Protocol CA209-816

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ended

Participants planned 386

Countries 4

Sites 16

Early Stage Non-Small Cell Lung Cancer (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: 15 Mar 2017 → 13 Dec 2024
Decision date (initial): 2023-04-28
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: 2022-501360-18-00
EudraCT number: 2016-003536-21
WHO UTN: U1111-1186-9445
ClinicalTrials.gov: NCT02998528

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

-To compare the event-free survival (EFS) by blinded independent central review (BICR) in participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>= 4 cm), II, or resectable IIIA (N2) NSCLC.
-To compare the pathologic complete response (pCR) rate in participants receiving nivolumab plus platinum doublet chemotherapy vs participants
receiving platinum doublet chemotherapy in operable stage IB (>= 4cm), II, or resectable IIIA (N2) NSCLC

Secondary objectives 3

To assess the major pathologic response (MPR) rate by BIPR of participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>=4 cm), II, or resectable IIIA (N2) NSCLC
To assess the OS of participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>=4 cm), II, or resectable IIIA (N2) NSCLC.
To assess the time to death or distant metastases (TTDM) of participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>=4 cm), II, or resectable IIIA (N2) NSCLC.

Conditions and MedDRA coding

Early Stage Non-Small Cell Lung Cancer (NSCLC)

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 4

Early stage (IB - IIIA), operable non-small cell lung cancer, confirmed in tissue.
Lung function capacity capable of tolerating the proposed lung surgery
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Available tissue of primary lung tumor.

Exclusion criteria 3

Presence of locally advanced, inoperable or metastatic disease.
Participants with active, known or suspected autoimmune disease.
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

Event-Free Survival
Pathological Complete Response

Secondary endpoints 3

Overall survival (OS)
Major pathological response (MPR)
Time to Death or Distant Metastases (TTDM)

Investigational products

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

Test 4

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD2941372 · Product

Active substance: Nivolumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 3 mg/Kg milligram(s)/kilogram
Max total dose: 9 mg/kg milligram(s)/kilogram
Max treatment duration: 6 Week(s)
Authorisation status: Authorised
ATC code: L01FF01 — -
Marketing authorisation: EU/1/15/1014/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

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: 3 mg/Kg milligram(s)/kilogram
Max total dose: 9 mg/Kg milligram(s)/kilogram
Max treatment duration: 6 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

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

Comparator 19

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

PRD6624336 · Product

Active substance: Gemcitabine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1250 mg/m2 milligram(s)/square meter
Max total dose: 7500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01BC05 — GEMCITABINE
Marketing authorisation: PL 04515/0224
MA holder: HOSPIRA UK LTD
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Clinical label for the purpose of this trial

Gemcitabine 1 g Powder for Solution for Infusion

PRD391098 · Product

Active substance: Gemcitabine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1250 mg/m2 milligram(s)/square meter
Max total dose: 7500 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01BC05 — GEMCITABINE
Marketing authorisation: PL 20075/0026
MA holder: ACCORD HEALTHCARE LIMITED
MA country: United Kingdom
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Clinical label for the purpose of this trial

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: 18 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: Yes
Modification description: clinical label for the purpose of this trial

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: 18 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: Yes
Modification description: clinical label for the purpose of this trial

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: Yes
Modification description: Clinical label for the purpose of this trial

Docetaxel Hospira 10 mg/ml Concentrate for Solution for Infusion

PRD4675098 · 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: 225 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CD02 — DOCETAXEL
Marketing authorisation: PL 04515/0370
MA holder: HOSPIRA UK LTD
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Clinical label for the purpose of this trial

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: 225 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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: Yes
Modification description: Clinical label for the purpose of this trial

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: 225 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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: Yes
Modification description: Clinical label for the purpose of this trial

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: Yes
Modification description: Clinical label for the purpose of this trial

Paclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD4549217 · 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: 600 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: PUREN PHARMA GMBH & CO. KG
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be removed from the carton, over-labeled, and repackaged. There will be no changes to the composition or primary packaging of the marketed products

TAXOL 6 mg/ml, concentrato per soluzione per infusione

PRD363782 · 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: 600 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CD01 — PACLITAXEL
Marketing authorisation: 028848024
MA holder: BRISTOL-MYERS SQUIBB S.R.L.
MA country: Italy
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be removed from the carton, over-labeled, and repackaged. There will be no changes to the composition or primary packaging of the marketed products

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: 600 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: Yes
Modification description: The product will be removed from the carton, over-labeled, and repackaged. There will be no changes to the composition or primary packaging of the marketed products

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: 600 mg/m2 milligram(s)/square meter
Max treatment duration: 9 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: The product will be removed from the carton, over-labeled, and repackaged. There will be no changes to the composition or primary packaging of the marketed products

Vinorelbin NC 10 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

PRD753835 · Product

Active substance: Vinorelbine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 180 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CA04 — VINORELBINE
Marketing authorisation: 66053.00.00
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

Navirel 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD536911 · Product

Active substance: Vinorelbine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 180 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CA04 — VINORELBINE
Marketing authorisation: 62819.00.00
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Clinical label for the purpose of this trial

Vinorelbin Aurobindo 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD4138277 · Product

Active substance: Vinorelbine Tartrate
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 180 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CA04 — VINORELBINE
Marketing authorisation: 69098.00.00
MA holder: PUREN PHARMA GMBH & CO. KG
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 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: 225 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: Yes
Modification description: Clinical overlabeling 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: 75 mg/m2 milligram(s)/square meter
Max total dose: 225 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: Yes
Modification description: Clinical label for the purpose of this trial

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)/square meter
Max total dose: 225 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: 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: Chaussee De La Hulpe 185
City: Watermael-Boitsfort
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 9

Organisation	City, country	Duties
Icon Laboratories Inc. ORG-100037135	Farmingdale, United States	Other
Myriad RBM Inc. ORG-100045698	Austin, United States	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Other, Data management
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other
Parexel International (IRL) Limited ORG-100022780	Dublin 2, Ireland	Other, Interactive response technologies (IRT)
Rules Based Medicine Inc. ORG-100043610	Austin, United States	Other
Q2 Solutions, 2 Squared Solutions LLC ORL-000001473	Valencia, CA, United States	Other
Q2 Solutions ORL-000000131	Livingston, United Kingdom	Other
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Data management, E-data capture

Locations

4 EU/EEA countries · 16 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ended	64	6
Italy	Ended	28	4
Romania	Ended	75	2
Spain	Ended	27	4
Rest of world United States, Argentina, Korea, Republic of, Japan, South Africa, China, Canada, Brazil, Taiwan, Turkey	—	192	—

Investigational sites

France

6 sites · Ended

Centre Hospitalier Regional Universitaire De Tours

Pneumologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9

Centre Hospitalier Universitaire De Toulouse

CHU Larrey - Departement Oncologie Cervico Thoracique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

Centre Hospitalier Universitaire De Rennes

Pneumologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9

Assistance Publique Hopitaux De Paris

GH Bichat, 46 Rue Henri Huchard, 75877, Paris Cedex 18

Institut Curie

Institut Curie, 26 Rue D Ulm, 75005, Paris

Centre Hospitalier Lyon Sud

Pneumologie, Chemin Du Grand Revoyet, 69310, Pierre Benite

Italy

4 sites · Ended

Azienda Unità Sanitaria Locale Della Romagna

Oncologia Medica, Via Alcide De Gasperi 8, 48121, Ravenna

IRCCS Ospedale Policlinico San Martino

UOS Tumori Polmonari, Largo Rosanna Benzi 10, 16132, Genoa

Istituto Tumori Bari Giovanni Paolo II

SSD Oncologia Medica per la Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari

University Hospital Of Perugia

S.C. Oncologia Medica, Via Gerardo Dottori 1, 06132, Perugia

Romania

2 sites · Ended

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

Spain

4 sites · Ended

Hospital Universitari Vall D Hebron

Departamento de Oncologia, Passeig De La Vall D Hebron 119-129, 08035, Barcelona

University Hospital Virgen Del Rocio S.L.

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

Hospital Universitario 12 De Octubre

Oncologia, Bloque D, Avenida De Cordoba S/n, Madrid

Hospital Universitario Puerta De Hierro De Majadahonda

Oncologia, Calle De Joaquin Rodrigo 2, 28222, Majadahonda

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end
France	2017-03-15	2024-12-03	2017-04-20	2019-10-25
Italy	2018-02-12	2024-12-04	2018-06-14	2019-11-05
Romania	2018-08-21	2024-12-06	2018-08-29	2019-11-15
Spain	2017-04-07	2024-12-06	2017-05-08	2019-11-19

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
2022-501360-18-00_Final Summary of Results SUM-108186	2025-11-26T13:08:25	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
2022-501360-18-00_Lay person summary	2025-11-14T13:42:34	Submitted	Laypersons Summary of Results
2022-501360-18-00_Lay person summary_FR	2025-12-12T16:13:02	Submitted	Laypersons Summary of Results
2022-501360-18-00_Lay person summary_IT	2026-01-26T16:53:04	Submitted	Laypersons Summary of Results

Documents 39 files

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

Type	Title	Version
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-data-appendices-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-safety-narratives-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-study-information-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-supplemental-figures-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-supplemental-tables-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-addend01-primary-csr-tp-synopsis-body-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-data-appendices-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-safety-narratives-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-study-information-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-supplemental-figures-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-supplemental-tables-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-interim-csr-tp-synopsis-body-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-erratum-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-safety-narratives-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-study-information-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-supplemental-figures-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-supplemental-tables-redacted	1
Clinical study report (for publication)	2022-501360-18-00_CA209816-primary-csr-tp-synopsis-body-redacted	1
Laypersons summary of results (for publication)	2022-501360-18-00_Lay person summary	N/A
Laypersons summary of results (for publication)	2022-501360-18-00_Lay person summary_FR	1
Laypersons summary of results (for publication)	2022-501360-18-00_Lay person summary_IT	1
Protocol (for publication)	D1_Protocol 2022-501360-18-00_redacted	1
Protocol (for publication)	D1_Protocol Administrative Letter 04 2022-501360-18-00_redacted	4
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC ALIMTA pemetrexed Lilly RSI	1
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Carboplatin Fresenius Kabi IE RSI	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Carboplatin Fresenius Kabi IE section 4.8	N/A
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Cisplatin NeoCorp Hexal DE RSI	1
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Docetaxel Hospira UK RSI	1
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Paclitaxel TAXOL RSI	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Vinorelbine NC Hexal DE RSI	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Vinorelbine NC Hexal DE_section 4.8_highlighted changes	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Gemcitabine Concentrate Hospira UK RSI	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Gemcitabine Concentrate Hospira UK RSI section 4.8_highlighted changes	N/A
Summary of results (for publication)	2022-501360-18-00_Final Summary of Results	N/A
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2022-501360-18-00_ENG	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ES_2022-501360-18-00_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_FR_2022-501360-18-00_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_IT_2022-501360-18-00_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_RO_2022-501360-18-00_Redacted	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-02-15	France	Acceptable 2023-04-28	2023-04-28
2	SUBSTANTIAL MODIFICATION	SM-1	2023-05-26	France	Acceptable 2023-07-28	2023-07-31
3	SUBSTANTIAL MODIFICATION	SM-2	2024-01-29	France	Acceptable 2024-03-12	2024-03-13
4	SUBSTANTIAL MODIFICATION	SM-3	2024-05-29	France	Acceptable 2024-07-26	2024-07-29
5	SUBSTANTIAL MODIFICATION	SM-5	2024-09-09	France	Acceptable 2024-11-28	2024-11-29