What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) such as carboplatin, etoposide, and nivolumab are associated with several side effects. Carboplatin and etoposide can cause myelosuppression, leading to neutropenia, anemia, and thrombocytopenia. Other side effects include nausea, vomiting, and fatigue. Nivolumab, an immune checkpoint inhibitor, can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Combining these treatments may increase the risk of these side effects, necessitating careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that combine chemotherapy with immunotherapy. Notably, atezolizumab in combination with carboplatin and etoposide was approved based on improved overall survival (OS) and progression-free survival (PFS) in patients with extensive-stage SCLC. Similarly, durvalumab combined with platinum-etoposide has shown improved survival outcomes and is FDA-approved for front-line treatment of extensive-stage SCLC. These treatments are similar to the combination being studied with BMS-986012, which also includes carboplatin, etoposide, and an immunotherapy agent (nivolumab).

What other types of research exist?

Promising, novel alternatives to BMS-986012 for Small Cell Lung Cancer patients include atezolizumab and durvalumab, both of which are anti-PD-L1 antibodies. These agents, when combined with platinum-etoposide chemotherapy, have shown improved survival outcomes in clinical trials.

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Alkylating agents

BMS-986012 + Chemotherapy + Nivolumab for Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Must not have

Active, known or suspected autoimmune disease or inflammatory disorder

Symptomatic brain or other central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986012 combined with three existing treatments to help newly diagnosed patients with severe lung cancer. The goal is to see if this combination can stop the cancer from growing better than the current treatments alone.

Who is the study for?

This trial is for adults with newly diagnosed extensive-stage small cell lung cancer (ES-SCLC). Participants must have good blood and organ function, at least one measurable tumor, and be able to use contraception if needed. They should not have had prior treatments for SCLC or certain health conditions like uncontrolled heart disease or active autoimmune diseases.

What is being tested?

The study tests the safety and effectiveness of BMS-986012 combined with carboplatin, etoposide, and nivolumab in improving survival without cancer progression. It's compared against a combination of just carboplatin, etoposide, and nivolumab as first-line therapy in ES-SCLC patients.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, nausea or vomiting due to chemotherapy drugs like carboplatin and etoposide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at an advanced stage and cannot be treated with just radiation.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune or inflammatory condition.

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I have symptoms from cancer spread to my brain or CNS.

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I have not had chemotherapy, radiation, or biologic therapy for small cell lung cancer.

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I have a serious heart condition that is not under control.

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I have moderate to severe numbness or tingling in my hands or feet.

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I need treatment for an immune system condition caused by my cancer.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Overall survival (OS)

Overall survival rate (OSR)

PFSR

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Carboplatin + Etoposide + NivolumabExperimental Treatment3 Interventions

Group II: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986012

2016

Completed Phase 1

~20

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960

Nivolumab

2015

Completed Phase 3

~4010

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and monoclonal antibodies. Chemotherapy agents like carboplatin and etoposide damage the DNA of cancer cells, preventing their division and growth. Immunotherapy drugs such as nivolumab enhance the immune system's ability to recognize and destroy cancer cells by targeting immune checkpoints like PD-1. Monoclonal antibodies, such as BMS-986012, target specific antigens on cancer cells, like fucosyl-GM1, leading to direct cancer cell killing or marking them for immune destruction. These treatments are vital for SCLC patients due to the aggressive nature of the disease, offering multiple mechanisms to attack cancer cells and potentially improve survival and quality of life.

Anti-ganglioside GM2 monoclonal antibody-dependent killing of human lung cancer cells by lymphocytes and monocytes.