A Study of BMS-986012 in Combination with Carboplatin, Etoposide, andNivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Overview

Sponsor-declared trial summary

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

1 Jun 2021 → 28 Nov 2025

Decision date (initial)

2024-06-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-510700-36-00

EudraCT number

2020-001863-10

WHO UTN

U1111-1250-4427

ClinicalTrials.gov

NCT04702880

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To assess the safety and tolerability for participants randomized to
BMS-986012 in combination with carboplatin, etoposide, and nivolumab
for 4 cycles (induction) followed by BMS-986012 and nivolumab
maintenance (Arm A) vs those randomized to carboplatin, etoposide, and
nivolumab for 4 cycles (induction) followed by nivolumab maintenance
(Arm B).
To compare the PFS as assessed by BICR of participants treated in the
combination induction and maintenance therapies of Arms A and B
described above.

Secondary objectives 6

1. To estimate the PFSR at 6 and 12 months in each treatment arm, based on PFS by RECIST v1.1 as assessed by BICR.
2. To compare PFS as assessed by investigator of participants treated in the combination induction and maintenance therapies of Arms A and B described above.
3. To estimate the PFSR at 6 and 12 months in each treatment arm based on PFS by RECIST v1.1 assessed by investigator.
4. To estimate the ORR, TTR, and DOR by RECIST v1.1 criteria by BICR and by investigator.
5. To assess OS of Arm A and Arm B and estimate OSR at 12 and 24 months by treatment arm.
6. To characterize the immunogenicity of BMS-986012 in combination with carboplatin, etoposide, and nivolumab in Arm A.

Conditions and MedDRA coding

Extensive-stage Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
2. At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) criteria
3. Adequate hematologic and end organ function
4. Must agree to follow specific methods of contraception, if applicable

Exclusion criteria 6

1. Women who are pregnant or breastfeeding
2. Paraneoplastic autoimmune syndrome requiring systemic treatment
3. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
4. Grade ≥ 2 peripheral sensory neuropathy at study entry
5. Significant uncontrolled cardiovascular disease
6. Active, known or suspected autoimmune disease or inflammatory disorder

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Incidence of adverse events (AEs)
2. Incidence of serious adverse events (SAEs)
3. Incidence of AEs leading to discontinuation
4. Incidence of deaths
5. Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

Secondary endpoints 9

1. 1. Progression-free survival rate (PFSR) [PFS by BICR based on RECIST v1.1 criteria]
2. PFS by investigator based on RECIST v1.1 criteria
3. PFSR at 6 and 12 months. PFS by investigator based on RECIST v1.1 criteria.
4. Objective response rate (ORR) based on RECIST v1.1 criteria
5. Time to response (TTR) based on RECIST v1.1 criteria
6. Duration of response (DOR) based on RECIST v1.1 criteria
7. Overall survival (OS)
8. Overall survival rate (OSR)
9. Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)

Investigational products

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

Test 3

Auxiliary 2

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

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 7

Locations

7 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

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

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

Documents 49 files

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

Application history

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