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Monoclonal Antibodies

BMS-986315 + Nivolumab + Chemotherapy for 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

Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease.

Study treatment must be first-line therapy for Stage IV or recurrent disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial evaluates a new combo of drugs to treat advanced lung cancer compared to current treatments.

Who is the study for?

This trial is for adults with Stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't had treatment for this stage. They must have measurable disease, expect to live at least 3 months, and be fairly active (ECOG 0-1). It's not for those with untreated brain metastases or certain gene mutations treatable by targeted therapies.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of BMS-986315 combined with nivolumab and chemotherapy versus just nivolumab with chemo in first-line treatment. Participants will receive platinum-based doublet chemotherapy as part of their regimen.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, nausea from chemo drugs like carboplatin and paclitaxel, blood count changes increasing infection risk.

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 stage IV or has come back after treatment for an advanced stage.

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My treatment for Stage IV or recurrent disease has not started yet.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Part 1: Number of Participants with AEs Leading to Death

Part 1: Number of Participants with AEs Leading to Discontinuation

Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria

+4 more

Secondary outcome measures

Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])

Part 2: Disease Control Rate (DCR)

Part 2: Duration of Response (DOR)

+9 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCTExperimental Treatment6 Interventions

Group II: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCTExperimental Treatment6 Interventions

Group III: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCTExperimental Treatment5 Interventions

Group IV: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCTExperimental Treatment5 Interventions

Group V: Part 2: Nivolumab + Histology-based PDCTActive Control5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Cisplatin

2013

Completed Phase 3

~1940

Nivolumab

2014

Completed Phase 3

~4750

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,868 Total Patients Enrolled

Frequently Asked Questions

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

In how many locations can participants access this experiment?

"Currently, the trial is being conducted in 13 locations such as MAYO (Rochester), The Medical University of South carolina (Charleston), and Swedish Cancer Institute (Seattle)."

Answered by AI

Does the FDA sanction Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT?

"With Phase 2 trials providing some evidence of safety but none for efficacy, our team at Power rated Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT with a score of two."

Answered by AI

Is enrollment still available for this trial?

"The clinical trial in question is no longer recruiting participants, with the first posting on November 3rd 2023 and the most recent edit being made October 17th 2023. Fortunately, alternative trials are readily available as there are 1809 other studies accepting patients presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

2023. "A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094296.

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