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Completed

NCT Number: NCT04702880

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

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0003, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], 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 taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
  • Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  • At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
  • Adequate hematologic and end organ function
  • Must agree to follow specific methods of contraception, if applicable

Exclusion criteria

  • Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
  • Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
  • Symptomatic brain or other central nervous system (CNS) metastases
  • Paraneoplastic autoimmune syndrome requiring systemic treatment
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
  • Grade ≥ 2 peripheral sensory neuropathy at study entry
  • Significant uncontrolled cardiovascular disease
  • Active, known or suspected autoimmune disease or inflammatory disorder

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986012

Biological

Specified dose on specified days

Other names: Fucosyl-GM1 Antibody

carboplatin

Drug

Specified dose on specified days

etoposide

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

  2. Number of Participants With Serious Adverse Events

    Time frame: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  3. Number of Participants With Adverse Events Leading to Discontinuation

    Time frame: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

  4. Number of Participants Who Died

    Time frame: From first dose to primary cutoff date (Up to approximately 43 months)

    Number of participants who died due to any cause.

  5. Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

    Time frame: From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)

    PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method.

    Progressive disease=At least a 20% increase in the sum of diameters of target lesions.

Secondary outcomes

  1. Progression Free Survival Rate (PFSR) at 6 and 12 Months

    Time frame: 6 and 12 months

    PFSR is defined as the percentage of participants progression free at 6 and 12 months. PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Blinded Independent Central Review (BICR) and by investigator, or death from any cause.

    Progressive disease=At least a 20% increase in the sum of diameters of target lesions.

  2. Progression Free Survival (PFS) Per Investigator

    Time frame: From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months)

    PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Investigator or death from any cause. Estimates are based on Kaplan-Meier product-limit method.

    Progressive disease=At least a 20% increase in the sum of diameters of target lesions.

  3. Objective Response Rate (ORR)

    Time frame: From randomization to the date of first documented response (Up to approximately 56 months)

    ORR per Blinded Independent Central Review (BICR) and per investigator is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.

  4. Duration of Response (DoR)

    Time frame: From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months)

    DoR per Blinded Independent Central Review and per investigator is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

    CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.

  5. Time to Response (TTR)

    Time frame: From randomization to the date of first documented CR or PR (Up to approximately 56 months)

    TTR per Blinded Independent Central Review (BICR) and per investigator is defined for participants who had a confirmed CR or PR as the time from the date of randomization to date of first documented CR or PR per RECIST v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.

  6. Overall Survival (OS)

    Time frame: From randomization to the date of death due to any cause (Up to approximately 56 months)

    OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.

  7. Overall Survival Rate (OSR) at 12 and 24 Months

    Time frame: 12 and 24 months

    OSR is defined as the percentage of participants surviving at 12 and 24 months. OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.

  8. Number of Participants With Anti-Nivolumab Antibody (ADA)

    Time frame: From baseline up to approximately 56 months

    ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. Baseline ADA Positive: A participant with baseline ADA-positive sample.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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