| CTRI Number |
CTRI/2025/11/097595 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two First-Time Treatment Combinations for Patients with Extensive-Stage Small Cell Lung Cancer |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012 +
Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide vs
Atezolizumab in Combination with Carboplatin plus Etoposide as First-line Therapy in
Participants with Extensive-Stage Small Cell Lung Cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2024-515740-23 |
EudraCT |
| CA245-0001 dated 20 Aug 2024 |
Protocol Number |
| U1111-1308-1151 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpi Sinha |
| Designation |
Director, Country Head RCO India |
| Affiliation |
Bristol Myers Squibb India Pvt Ltd |
| Address |
Bristol Myers Squibb India Pvt. Ltd One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone(W), Mumbai-400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02266288600 |
| Fax |
|
| Email |
Shilpi.Sinha@bms.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kartik Doshi |
| Designation |
Associate Director, Medical India |
| Affiliation |
Bristol Myers Squibb India Pvt Ltd |
| Address |
Bristol Myers Squibb India Pvt. Ltd One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone(W), Mumbai-400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02266288600 |
| Fax |
|
| Email |
Kartik.Doshi@bms.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpi Sinha |
| Designation |
Director, Country Head RCO India |
| Affiliation |
Bristol Myers Squibb India Pvt Ltd |
| Address |
Bristol Myers Squibb India Pvt. Ltd One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone(W), Mumbai-400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02266288600 |
| Fax |
|
| Email |
Shilpi.Sinha@bms.com |
|
|
Source of Monetary or Material Support
|
| Bristol Myers Squibb India Private Limited, One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W),
Mumbai- 400013, India |
|
|
Primary Sponsor
|
| Name |
Bristol Myers Squibb India Private Limited |
| Address |
One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Czech Republic
France
Germany
Greece
Italy
Japan
Malaysia
Mexico
Netherlands
Poland
Romania
Spain
Switzerland
Turkey
United Kingdom
Republic of Korea
United States of America |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saju S V |
Meenakshi Mission Hospital & Research Centre |
Department of Clinical research, 1st floor,
Oncology Building, Lake Area, Melur Road, Madurai - 625107, Tamil Nadu, India
Madurai
TAMIL NADU |
7904423513
drsajusv@gmail.com |
| Dr Sachin Khurana |
All India Institute of Medical Sciences |
Room Number 1015, 1st Floor, New Private ward, Ansari Nagar, Delhi - 110029
New Delhi
DELHI |
9369030180
dr.sachinkhurana@gmail.com |
| Dr Bipinesh Sansar |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
Sundar Bagiya, Varanasi, Uttar Pradesh, India, 221005
Varanasi
UTTAR PRADESH |
8002583913
bipinesh04@yahoo.co.in |
| Dr Amit Rauthan |
Manipal Hospital |
98 HAL Old Airport Road, Bengaluru, Karnataka, India, 560017
Bangalore
KARNATAKA |
9880463958
amitrauthan@yahoo.com |
| Dr Poulami Basu |
Netaji Subhas Chandra Bose Cancer Hospital |
3081 Nayabad, New Garia, Kolkata-700094, West Bengal, India
Kolkata
WEST BENGAL |
6290073778
poulamibasu18386@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee N.S.C.B.C Research Institute |
Approved |
| Ethics Committee of Manipal Hospitals |
Approved |
| IEC, MPMMCC and HBCH Varanasi |
Submittted/Under Review |
| Institutional Ethics Committee - AIIMS |
Submittted/Under Review |
| Institutional Ethics Committee - Meeenakshi Mission |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A: BMS 986489 FDC (BMS 986012 + Nivolumab) + Carboplatin + Etoposide |
Treatment is of approximately 26 cycles (each cycle is of 3 weeks). Following drug will be administered:
1) BMS 986489:
a) Induction period of 4 cycles - BMS 986012 420 mg + Nivolumab 360 mg - Intravenous
b) Maintenance period from cycle 5 and beyond - BMS 986012 560 mg + Nivolumab 480 mg - Intravenous
2) Carboplatin 450mg day 1 of cycle 1 to 4 - Intravenous
3) Etoposide 100mg day 1 of cycle 1 to 4 - Intravenous |
| Intervention |
Arm B: Atezolizumab + Carboplatin + Etoposide |
Treatment is of approximately 26 cycles (each cycle is of 3 weeks). Following drug will be administered: 1) Atezolizumab 1200 mg in Induction period of 4 cycles - Subcutaneous b) Atezolizumab 1680 mg in Maintenance period from cycle 5 and beyond - Subcutaneous 2) Carboplatin 450mg day 1 of cycle 1 to 4 - Intravenous 3) Etoposide 100mg day 1 of cycle 1 to 4 - Intravenous |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participant must be at least 18 years of age or local age of majority at the time of signing
the ICF
Participants must have histologically or cytologically documented SCLC Participants must have extensive stage disease Stage IV or T3 -4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan
Participants must have at least 1 measurable lesion outside the central nervous system by computed tomography or magnetic resonance imaging per RECIST v1.1 criteria
Participants who have received prior chemotherapy/chemoradiotherapy for LS SCLC are eligible if treatment was completed at least 6 months prior to initiating study treatment
Eastern Cooperative Oncology Group performance status of 0 or 1
Participants must be suitable to receive platinum-based chemotherapy regimen as well as anti PD L 1 based regimens as per locally approved drug labels and institutional guidelines
|
|
| ExclusionCriteria |
| Details |
Prior treatment for ES-SCLC Note Treatment of CNS metastases with local treatment including radiation and or surgery is permitted
Untreated symptomatic CNS metastases
Leptomeningeal disease
Malignancy related superior vena cava syndrome that requires urgent radiation or may require urgent radiation in the immediate future per the Investigator
Pleural effusion that cannot be controlled with appropriate interventions
Concurrent malignancy
Grade less than or equal to 2 peripheral sensory neuropathy
Participants with active, known or suspected autoimmune disease
Prior treatment with an anti PD 1 anti PD L1 or anti CTLA 4 antibody or any other antibody or drug specifically targeting T cell co stimulation or checkpoint pathways
Prior treatment with an anti fuc GM1 therapy or any other drug specifically targeting fucosyl GM1 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Overall Survival of participants with ES-SCLC randomized to Arm A and Arm B. |
From randomization until death from any cause. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare time to disease-related symptom deterioration
2 To assess safety
3 Objective response as assessed by the investigator
4 Estimate Duration of response as assessed by the investigator
5 Progression free survival as assessed by the investigator |
1)Time to definitive deterioration (LCSS ASBI)-Time from randomization to a clinically meaningful decline (more than or equal to 10-point increase from baseline).
2)Incidence of AEs-Includes AEs, SAEs, AEs leading to discontinuation, & death.
3)OR-Best overall response of CR or PR.
4)DOR-Time from first response to PFS event.
5)PFS-Time from randomization to first documented progression or death. |
|
|
Target Sample Size
|
Total Sample Size="530"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to measure the overall survival benefit of BMS 986489 with 4 cycles of chemotherapy followed by BMS 986489 maintenance compared with atezolizumab with 4 cycles of chemotherapy followed by atezolizumab maintenance as first line therapy in participants with ES-SCLC Study details include the following 1 Study Duration Up to 5 years from randomization of the last participant or until the final date on which the data for primary endpoint OS are collected whichever occurs later 2 Study Intervention Duration Participants will be treated until investigator assessed radiographic disease progression by RECIST v1.1 unacceptable toxicity death or withdrawal of consent whichever comes first 3 Study Visit Frequency Every 3 weeks for 4 cycles during induction followed by every 4weeks during maintenance |