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

NCT04702880

CompletedPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Extensive-stage Small Cell Lung Cancer

Interventions: BMS-986012, Carboplatin, Etoposide, Nivolumab

Countries: United States, Australia, Belgium, Canada, Greece, Italy, Japan, Netherlands

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (39)
  • Birmingham, Alabama, United States
  • Hackensack, New Jersey, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Westmead, New South Wales, Australia
  • Greenslopes, Queensland, Australia
  • Malvern, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Charleroi, Hainaut, Belgium
  • Ghent, Belgium
  • Liège, Belgium
  • Edmonton, Alberta, Canada
  • Brampton, Ontario, Canada
  • Heraklion, Irakleío, Greece
  • Athens, Greece
  • Athens, Greece
  • Peschiera del Garda, Italy
  • Pisa, Italy
  • Rozzano, Italy
  • Sendai, Miyagi, Japan
  • Ōsaka-sayama, Osaka, Japan
  • Takatsuki, Osaka, Japan
  • Ina-machi, Saitama, Japan
  • Amsterdam, North Holland, Netherlands
  • Arnhem, Netherlands
  • Groningen, Netherlands
  • + 9 more on CT.gov