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Alkylating agents

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

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will test if a new drug combo is better than current standard of care for a certain type of lung cancer.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of AEs leading to discontinuation

Incidence of adverse events (AEs)

Incidence of deaths

+2 more

Secondary outcome measures

Duration of response (DOR) based on RECIST v1.1 criteria

Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)

Objective response rate (ORR) based on RECIST v1.1 criteria

+6 more

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

~10

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

Nivolumab

2014

Completed Phase 3

~4750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,944 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04702880 — Phase 2

Small Cell Lung Cancer Research Study Groups: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012, Arm B: Carboplatin + Etoposide + Nivolumab

Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04702880 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04702880 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there extant studies detailing the efficacy of BMS-986012?

"Currently, there are 1548 ongoing investigations into BMS-986012 with 338 trials being conducted during the third stage. Numerous medical sites in Shanghai alone have initiated studies of this drug; 86028 total locations have active clinical trial programs for it."

Answered by AI

What primary condition is BMS-986012 typically utilized to treat?

"BMS-986012 is a commonly prescribed medication for metastatic hepatocellular carcinoma. It also has demonstrated efficacy in treating lymphoma, non-Hodgkin's malignant melanoma of the skin, and Merkel cell cancer."

Answered by AI

Are there any ongoing opportunities to join this experiment?

"According to the information accessible on clinicaltrials.gov, this medical trial is currently enrolling participants. It was initially created on March 17th of 2021 and last edited on September 30th 2022."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned BMS-986012 for use?

"Our team at Power gives BMS-986012 a 2 rating due to the presence of some data attesting its safety, yet no clinical evidence in support of efficacy."

Answered by AI

How many participants are currently involved in this trial?

"For the successful completion of this trial, a total of 120 participants who meet the criteria need to be recruited. The sponsor, Bristol-Myers Squibb is running it from two locations: Local Institution - 0012 in Edmonton, Alberta and MultiCare Health System in Tacoma, Washington."

Answered by AI

Are there any Canadian medical centers running this clinical investigation?

"Patients are being accepted at Local Institution - 0012 in Edmonton, Alberta, MultiCare Health System in Tacoma, Washington, and University of Alabama at Birmingham in Birmingham. Additionally there are 18 additional enrolment sites around the continent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04702880.

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