Clinical Trials /

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

NCT04702880

Description:

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).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CA001-050
  • SECONDARY ID: 2020-001863-10
  • SECONDARY ID: U1111-1250-4427
  • NCT ID: NCT04702880

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DrugSynonymsArms
BMS-986012Fucosyl-GM1 AntibodyArm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
CarboplatinArm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
EtoposideArm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
NivolumabBMS-936558Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012Experimental
  • BMS-986012
  • Carboplatin
  • Etoposide
  • Nivolumab
Arm B: Carboplatin + Etoposide + NivolumabExperimental
  • Carboplatin
  • Etoposide
  • Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically or cytologically documented extensive-stage small cell lung cancer
             (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 7th
             edition, Stage IV [T any, N any, M1a, or M1b], 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)

          -  Must provide a fresh tumor biopsy from the primary disease site (when possible) or
             from any metastatic site when the primary site is not available

          -  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 (Response
             Evaluation Criteria in Solid Tumors (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

          -  Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer
             (SCLC) for first-line treatment

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs)
Time Frame:Up to 2 years and 100 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival rate (PFSR)
Time Frame:6 and 12 months
Safety Issue:
Description:PFS by BICR based on RECIST v1.1 criteria
Measure:PFS by investigator based on RECIST v1.1 criteria
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:PFSR
Time Frame:6 and 12 months
Safety Issue:
Description:PFS by investigator based on RECIST v1.1 criteria
Measure:Objective response rate (ORR) based on RECIST v1.1 criteria
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Time to response (TTR) based on RECIST v1.1 criteria
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Duration of response (DOR) based on RECIST v1.1 criteria
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:By arm
Measure:Overall survival rate (OSR)
Time Frame:Up to 3 years
Safety Issue:
Description:By arm
Measure:Measures of tumor fucosyl-GM1 (fuc-GM1) expression by immunohistochemistry (IHC)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (IHC)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Measures of tumor fucosyl-GM1 (fuc-GM1) expression by targeted mass spectrometry
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (targeted mass spectrometry)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Measures of tumor programmed cell death-ligand 1 (PD-L1) expression combined positive score (CPS) at baseline
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Measures of tumor programmed cell death-ligand 1 (PD-L1) expression association with measures of anti-tumor activity (eg, ORR, PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure: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)
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • BMS-986012
  • Carboplatin
  • Etoposide
  • Extensive-stage small cell lung cancer
  • Fucosyl
  • Nivolumab
  • Targeted SCLC therapy

Last Updated

April 19, 2021