Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
530
Countries
11
Sites
68
Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
The main goal of this study is to compare whether BMS-986489 FDC, when used with chemotherapy medicines helps people live longer compared with people who take chemotherapy medicines and atezolizumab.
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
- 25 Mar 2025 → ongoing
- Decision date (initial)
- 2025-03-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2024-515740-23-00
- WHO UTN
- U1111-1308-1151
- ClinicalTrials.gov
- NCT06646276
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Others, Pharmacodynamic, Efficacy, Therapy
The main goal of this study is to compare whether BMS-986489 FDC, when used with chemotherapy medicines helps people live longer compared with people who take chemotherapy medicines and atezolizumab.
Secondary objectives 5
- Compare the two treatment arms for disease-related symptoms.
- Compare the two treatment arms for safety (i.e. side effects).
- Compare the two treatment arms for how many people's disease gets better (i.e. "response rate").
- Compare the two treatment arms for how long the disease stays better (i.e. "duration of response").
- Compare the two treatment arms for how long participants live in each treatment group before their disease gets worse (i.e. Progression Free Survival).
Conditions and MedDRA coding
Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Diagnosis of ES-SCLC
- Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
- At least one tumour that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system.
Exclusion criteria 2
- People have already received certain types of treatment for extensive stage small cell lung cancer.
- People have certain health conditions, like spread of small cell lung cancer to the brain and meninges that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall survival: how long participants live after entering the study (i.e. after randomization)
Secondary endpoints 5
- Time for disease related symptoms to get worse (TTDD).
- Safety: side effects, the number of side effects, type, severity, seriousness, and outcome.
- Response: measurements to indicate how many patients' tumors shrink or disappear after treatment (Overall Response).
- How long the tumors stay shrunk or disappear (Duration of Response)
- The time during and after treatment that a participant lives without their disease getting worse (Progression Free Survival).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11665759 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 3
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 mg/ml milligram(s)/millilitre
- Max total dose
- 3000 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB178312 · Substance
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1680 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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
- 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 8
| Organisation | City, country | Duties |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other, Laboratory analysis |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other, Interactive response technologies (IRT) |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
Locations
11 EU/EEA countries · 68 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 11 | 4 |
| Belgium | Ongoing, recruitment ended | 11 | 4 |
| Czechia | Ongoing, recruitment ended | 11 | 4 |
| France | Ongoing, recruitment ended | 30 | 10 |
| Germany | Ongoing, recruiting | 30 | 9 |
| Greece | Ongoing, recruitment ended | 15 | 5 |
| Italy | Ongoing, recruitment ended | 21 | 7 |
| Netherlands | Ongoing, recruitment ended | 9 | 3 |
| Poland | Ongoing, recruitment ended | 18 | 5 |
| Romania | Ongoing, recruitment ended | 25 | 7 |
| Spain | Ongoing, recruitment ended | 31 | 10 |
| Rest of world
Argentina, Brazil, Mexico, Japan, Korea, Republic of, Canada, Turkey, India, China, Malaysia, United Kingdom, United States, Switzerland, Australia, Chile
|
— | 318 | — |
Investigational sites
Landeskrankenhaus Rankweil
Department for Internal Medicine II, Valdunastrasse 16, 6830, Rankweil
Medical University Of Graz
Clinical Department for Pneumology, Neue Stiftingtalstrasse 6, 8010, Graz
Klinikum Wels-Grieskirchen GmbH
Department for Lung Diseases, Grieskirchner Strasse 42, 4600, Wels
Kepler Universitaetsklinikum GmbH
Internal Medicine 4 - Pneumology, Krankenhausstrasse 9, 4020, Linz
Centre Hospitalier Universitaire De Liege
Pneumology, Avenue De L'hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Vitaz
Pulmonary and infectious diseases, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
Pneumology, Corneel Heymanslaan 10, 9000, Gent
University Hospital Olomouc
Klinika plicnich nemoci a tuberkulozy, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Thomayerova nemocnice
Pneumologicka klinika 1. LF UK a FTN, Videnska 750/800, Krc, Prague 4
Masarykuv Onkologicky Ustav
Oddeleni C - oddeleni klinicke onkologie, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Nemocnice AGEL Ostrava-Vitkovice a.s.
Plicni oddeleni, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Centre Hospitalier Universitaire De Montpellier
Oncologie Thoracique, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Regional De Marseille
Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Curie
Pneumologie, 26 Rue D Ulm, 75005, Paris
Les Hopitaux Nord-Ouest
Pneumologie, Plateau D Ouilly, Cs 80436 Gleize, Villefranche Sur Saone Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Pôle Thorax et Vaisseaux Service universitaire de Pneumologie Unité d'oncologie Thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Institut Gustave Roussy
Oncologie médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Lille
Pneumologie et Oncologie Thoracique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hospices Civils De Lyon
Pneumologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Intercommunal De Cornouaille
Pneumologie Oncologie, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Hospitalier Intercommunal Creteil
Pneumologie Oncologie thoracique, 40 Avenue De Verdun, 94000, Creteil
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Robert Bosch Krankenhaus Lungenzentrum, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Kliniken der Stadt Koeln gGmbH
Lungenkrebszentrum, Ostmerheimer Strasse 200, Merheim, Cologne
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Studiensekretariat, MVZ, E0, Roentgenstrasse 1, Doelau, Halle (saale)
Thoraxklinik Heidelberg gGmbH
Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Asklepios Klinik Gauting GmbH
Thorakale Onkologie, Robert-Koch-Allee 2, 82131, Gauting
Krankenhaus Nordwest GmbH
Thoraxonkologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Zentralklinik Bad Berka GmbH
Internistische Hämatologie und Onkologie, Robert-Koch-Allee 9, 99437, Bad Berka
Pius-Hospital Oldenburg
Klinik für Hämatologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
General University Hospital Of Larissa
Oncology Clinic, Chemotherapy Department, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine, Oncology Unit & Laboratory, Messogion Avenue 152, 115 27, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Theageneio Cancer Hospital
2nd Department of Oncology Clinic, Simeonidi Alex 2, 546 39, Thessaloniki
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology 1, Via Giacomo Venezian 1, 20133, Milan
Istituto Europeo Di Oncologia S.r.l.
Thoracic oncology Division, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Santa Maria Della Misericordia
Medical Oncology, Piazzale Giorgio Menghini 1, 06129, Perugia
IRCCS Istituto Nazionale Tumori Fondazione Pascale
thoracopulmonary department, Via Mariano Semmola 142, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncology hematology department, Via Pietro Albertoni 15, 40138, Bologna
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
U.O. di Oncologia Toracica, Lung Unit, Via Monte Baldo 24, 37019, Peschiera Del Garda
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Amsterdam UMC Stichting
Lung, De Boelelaan 1117, 1081 HV, Amsterdam
Rijnstate Ziekenhuis Stichting
Lung, Wagnerlaan 55, 6815 AD, Arnhem
Universitair Medisch Centrum Groningen
Lung, Hanzeplein 1, 9713 GZ, Groningen
Pratia S.A.
Centrum Medyczne Pratia Poznań, Ul. Poznanska 14, 60-185, Skorzewo
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Przychodnia Lekarska KOMED
N/A, ul. Wojska Polskiego 6, 62-500, Konin
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddział Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Centrul De Oncologie-Euroclinic S.R.L.
Oncologie Medicala, Strada Conta Vasile 2, 700106, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncologie Medicala, Soseaua Fundeni 252, 022328, Bucharest
Memorial Healthcare International S.R.L.
Ongologie Medicala, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-03-27 | 2025-05-15 | 2026-03-31 | ||
| Belgium | 2025-07-08 | 2025-07-28 | 2026-03-31 | ||
| Czechia | 2025-04-28 | 2025-05-05 | 2026-03-31 | ||
| France | 2025-03-25 | 2025-03-26 | 2026-03-31 | ||
| Germany | 2025-04-01 | 2025-04-08 | |||
| Greece | 2025-04-09 | 2025-05-05 | 2026-04-07 | ||
| Italy | 2025-04-03 | 2025-04-23 | 2026-03-31 | ||
| Netherlands | 2025-04-09 | 2025-07-09 | 2026-03-31 | ||
| Poland | 2025-03-25 | 2025-04-16 | 2026-03-31 | ||
| Romania | 2025-03-25 | 2025-03-26 | 2026-03-31 | ||
| Spain | 2025-03-26 | 2025-04-08 | 2026-03-31 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-84642
- Halt date
- 2025-05-20
- Member states concerned
- Netherlands
- Publication date
- 2025-05-29
- Reason
- Study management related
- Explanation
- Please be informed that the attached memorandum has been sent to the investigators, informing them of the Temporary Enrollment and Site Activation Hold in the EU for study CA245-0001. This decision is not linked to any safety concerns. The sponsor would like to inform due to rapid enrollment in the EU region, the CA245-0001 study team has reached the difficult decision to place European Union, Switzerland, and Turkey enrollment and Site Activation ON A TEMPORARY HOLD. This temporary enrollment hold is due to shortage of central supply of Carboplatin, Etoposide, and Atezolizumab.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 112 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol EU CT 2024-515740-23-00_GR_Redacted | 02 EU |
| Protocol (for publication) | D1_Protocol Admin Letter admin letter 01_2024-515740-23-00-Redacted | 1.0 |
| Protocol (for publication) | D1_Protocol Admin Letter admin letter 02_2024-515740-23-00-Redacted | 2.0 |
| Protocol (for publication) | D1_Protocol_2024-515740-23-00_Redacted | 02 EU |
| Protocol (for publication) | D4_Statement on copyrighted questionnaire_LCSS | N/A |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1 Template recruitment arrangements IT | 2 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment and Informed consent procedure | V01 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement form_PL | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_AT | 02 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 02 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material Brochure ES-SCLC_clean_updated | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material Brochure ES-SCLC_GR | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material Brochure ES-SCLC_TC_updated | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material PI to Patient Letter_clean_updated | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material PI to Patient Letter_GR | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment material PI to Patient Letter_TC_updated | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BMS037027 TIGOS_RecruitmentBrochure_M_ES | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_RecruitmentBrochure_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Social Media Statement_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Social Media Statement_DE | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_ PI to patient letter_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_ Recruitment Brochure_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recrutiment material_37028_BMS_TIGOS_PI-to-Patient Letter_V1_ES | 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_DE_SIS and ICF Main_redated | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Optional Future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF main redacted_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF optional future research_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF pregnant participant_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF pregnant partner_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF treatment beyond progression_NLD | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS an ICF_Treatment beyond Disease Progression_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Main CA245-0001_AUT_V 01_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Optional Future Research CA245-0001_AUT_V01 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Pregnant Partner_CA245-0001_AUT_V01 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Treatment Beyond Progression CA245-0001_AUT_V01 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Future Research_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for travel reimbursement_clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Treatment beyond Progression_clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_ ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main__Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_Redacted_IT | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future research | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future research_Redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partecipant_unredacted_IT | 1 |
| 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 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_unredacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy Notice_Redacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_Redacted_IT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Tx Beyond Progression_unredacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_ENG_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_FRA_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_NLD_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant_ENG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant_FRA_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant_NLD_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_ENG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_FRA_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner_NLD_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_sponsorstatement BMS_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP_ENG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP_FRA_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP_NLD_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_FR | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_Future Research_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_T Beyond PG_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Personal Data Processing_CZ | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atezolizumab_RSI and QUALITY | Rev 32 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atezolizumab_Summary of changes_EN | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Carboplatin Accord RSI | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Etoposide ETO-cell STADAPHARMA RSI | N/A |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis GR 2024-515740-23 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-515740-23-00_CZ_CS | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-515740-23_NLD | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis__2024-515740-23_AUT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis__2024-515740-23_IT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515740-23_BE_DEU | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515740-23_BE_FRA | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515740-23_BE_NLD | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515740-23_ES | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515740-23_FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-515740-23_PL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-515740-23_RO | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2024-515740-23-00 | 1 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | Germany | Acceptable 2025-03-07
|
2025-03-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-17 | Acceptable 2025-03-07
|
2025-03-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-17 | Acceptable 2025-03-07
|
2025-03-17 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-20 | Acceptable | 2025-04-16 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-21 | Acceptable | 2025-04-01 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-16 | Acceptable | 2025-04-16 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-29 | Germany | Acceptable | 2025-04-29 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-09 | Acceptable | 2025-05-09 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-12 | Acceptable | 2025-05-12 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-05-15 | Acceptable | 2025-05-15 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-23 | Germany | Acceptable 2025-08-25
|
2025-08-26 |
| 12 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-10 | Germany | Acceptable | 2025-12-10 |
| 13 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-10 | Acceptable | 2025-11-23 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-02-19 | Acceptable | 2026-02-19 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2026-03-18 | Acceptable | 2026-03-18 |