What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors like nivolumab and pembrolizumab, and platinum-based chemotherapies. Immune checkpoint inhibitors can cause fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Platinum-based chemotherapies often result in nausea, vomiting, nephrotoxicity, neurotoxicity, myelosuppression, and increased infection risk. Combining these treatments can lead to overlapping side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that are similar to the investigational agent BMS-986315. Notable approvals include immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target the PD-1/PD-L1 pathway and have shown efficacy in combination with chemotherapy. Additionally, tyrosine kinase inhibitors (TKIs) like gefitinib, erlotinib, and osimertinib, which target EGFR mutations, have been approved for specific subsets of NSCLC patients. These treatments have significantly advanced the management of NSCLC by improving overall survival and progression-free survival in various patient populations.

What other types of research exist?

Promising, novel alternatives to BMS-986315 for NSCLC patients include: 1) Nivolumab in combination with platinum-based doublet chemotherapy (PDCT), which is being evaluated for its efficacy and safety in first-line treatment of Stage IV or recurrent NSCLC. 2) BMS-690514, an oral tyrosine kinase inhibitor targeting ErbB and VEGF receptors, which has shown preliminary efficacy in advanced or metastatic solid tumors. 3) Pembrolizumab plus cetuximab, which is being investigated for treatment-refractory metastatic head and neck cancer and may have potential applications in NSCLC. These alternatives are in various stages of clinical trials and have shown promise in targeting specific pathways involved in cancer progression.

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Monoclonal Antibodies

BMS-986315 + Nivolumab + Chemotherapy for 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

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.

Must not have

Untreated symptomatic central nervous system metastases

Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug combined with an existing cancer drug and standard chemotherapy to treat patients with advanced or returning lung cancer. The goal is to see if this combination works better than the current treatment by boosting the immune system and killing cancer cells.

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.

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.

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.

Exclusion Criteria

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

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I have brain metastases that have not been treated and are causing symptoms.

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My cancer has specific mutations that can be treated with targeted therapies.

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

Awards & Highlights

No Placebo-Only Group

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

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

Nivolumab

2015

Completed Phase 3

~4010

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450

BMS-986315

2023

Completed Phase 2

~10

Cisplatin

2013

Completed Phase 3

~3120

Pemetrexed

2014

Completed Phase 3

~5550

0 / 5Eligibility 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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically target molecular abnormalities in cancer cells, resulting in fewer side effects and improved efficacy for patients with certain genetic mutations. Immunotherapies, like nivolumab, enhance the immune system's ability to fight cancer by inhibiting checkpoints that prevent immune activation. Investigational agents like BMS-986315 likely target specific pathways in cancer cells, offering new mechanisms of action. These treatments are vital for NSCLC patients as they provide more personalized and effective options, improving outcomes and quality of life.

Emerging therapeutic agents for lung cancer.Targeted therapy for the treatment of advanced non-small cell lung cancer: a review of the epidermal growth factor receptor antagonists.Systemic therapy for lung cancer brain metastases: a rationale for clinical trials.