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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 belowSelect...
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:Select...
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
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 moreAwards & 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
2014
Completed Phase 3
~5220
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.
Anti-ganglioside GM2 monoclonal antibody-dependent killing of human lung cancer cells by lymphocytes and monocytes.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,783 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune or inflammatory condition.I have symptoms from cancer spread to my brain or CNS.I have not had chemotherapy, radiation, or biologic therapy for small cell lung cancer.I have a serious heart condition that is not under control.If you want to take part in the PET tracer sub-study, you need to provide a recent tumor biopsy from any location where the cancer is found.I have moderate to severe numbness or tingling in my hands or feet.I need treatment for an immune system condition caused by my cancer.My lung cancer is at an advanced stage and cannot be treated with just radiation.My blood and organs are functioning well.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I can provide samples of my tumor, unless I'm in the PET tracer study.I have at least one tumor that can be measured on a scan.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
- Group 2: Arm B: Carboplatin + Etoposide + Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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