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Trial ID CA001-050  |   NCT04702880

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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)
    1. Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
      1. 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
        1. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
          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
            1. Adequate hematologic and end organ function
              1. Must agree to follow specific methods of contraception, if applicable

                Exclusion Criteria

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

                                Treatment Options

                                Study Arms

                                ASSIGNED INTERVENTION

                                Study Arms

                                Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012

                                ASSIGNED INTERVENTION
                                • Biological: BMS-986012, Nivolumab
                                • Drug: Carboplatin, Etoposide

                                Study Arms

                                Experimental: Arm B: Carboplatin + Etoposide + Nivolumab

                                ASSIGNED INTERVENTION
                                • Drug: Carboplatin, Etoposide
                                • Biological: Nivolumab

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