Study on BMS-986012 with Carboplatin, Etoposide, and Nivolumab for First-time Treatment of Extensive-stage Small Cell Lung Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04702880

This clinical trial is testing a new combination of drugs, including BMS-986012, with standard chemotherapy and immunotherapy to see if it is safe and can better control extensive-stage small cell lung cancer (ES-SCLC) compared to the standard treatment alone.

Patient Parameters

Program Overview

The aim of this study is to find out if adding a new drug, BMS-986012, to the usual treatment of carboplatin, etoposide, and nivolumab can safely improve how long patients with extensive-stage small cell lung cancer (ES-SCLC) live without their cancer getting worse, compared to the standard treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) that is too widespread for surgery or radiation.
  • If participating in a specific sub-study, provide a new tumor sample from any cancer site.
  • Provide a previous tumor sample for analysis, unless participating in the sub-study where this is optional.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one tumor that can be measured by scans.
  • Have good blood and organ function as shown by medical tests.
  • Agree to use effective birth control methods, if applicable.

Exclusion Criteria

  • Women who are pregnant or breastfeeding. In Japan, participation is not allowed even if breastfeeding is paused.
  • Have had previous chemotherapy, radiation, or biological therapy for small cell lung cancer (SCLC). Those who have been treated for limited-stage SCLC are also excluded.
  • Have cancer that has spread to the brain or central nervous system and is causing symptoms.
  • Have a condition called paraneoplastic autoimmune syndrome that needs treatment.
  • Have a history of certain lung diseases like idiopathic pulmonary fibrosis or active lung inflammation.
  • Have significant nerve damage in the hands or feet.
  • Have serious heart disease that is not controlled.
  • Have an active autoimmune disease or inflammatory disorder.

Other specific criteria may apply.

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