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 various chemotherapies. Nivolumab can cause side effects such as fatigue, rash, diarrhea, and immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy agents, such as carboplatin, paclitaxel, and pemetrexed, often lead to nausea, vomiting, decreased blood cell counts (neutropenia, anemia, thrombocytopenia), hair loss, and an increased risk of infection.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and combination therapies. Pembrolizumab, an anti-PD-1 therapy, has been approved for use in combination with chemotherapy for advanced NSCLC, as demonstrated in the KEYNOTE-407 trial. Nivolumab, another anti-PD-1 therapy, is also approved for NSCLC and is often used in combination with other treatments. Additionally, the MET inhibitor capmatinib is approved for NSCLC with MET exon-14-skipping mutations. These treatments aim to enhance the immune system's ability to fight cancer and are similar in approach to the investigational combination of BMS-986442 with nivolumab.

What other types of research exist?

Promising alternatives to BMS-986442 for NSCLC patients include: 1) Dabrafenib plus trametinib for patients with BRAF V600E mutations, which is FDA approved and has shown significant efficacy. 2) Fam-trastuzumab deruxtecan for patients with HER2 exon-20-insertion mutations, also FDA approved. 3) Adagrasib, a KRAS G12C inhibitor, though not yet approved, has shown potential in clinical trials. These treatments offer targeted approaches based on specific genetic mutations in NSCLC.

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Monoclonal Antibodies

BMS-986442 + Nivolumab for Lung Cancer

Phase 1 & 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 an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Be older than 18 years old

Must not have

Untreated symptomatic central nervous system metastases or leptomeningeal metastases.

Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.

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 called BMS-986442 together with nivolumab, and sometimes chemotherapy, to see if it can help fight cancer more effectively.

Who is the study for?

This trial is for adults with certain types of lung or solid tumors who are in fairly good physical condition (able to carry out daily activities with ease or minor limitations) and expected to live at least 3 more months. They must have measurable tumor growth that can be tracked over time. People with untreated brain metastases, another cancer needing treatment, or active autoimmune diseases cannot join.

What is being tested?

The study tests BMS-986442 combined with Nivolumab, a type of immunotherapy, and may include chemotherapy drugs like Pemexetred, Paclitaxel, Docetaxel, or Carboplatin. The goal is to see if this combination helps shrink the tumors better than current treatments.

What are the potential side effects?

Possible side effects might include immune-related reactions affecting different organs which could cause symptoms like fatigue, skin rash or digestive issues; infusion reactions during drug administration; and typical chemotherapy side effects such as nausea and hair loss.

Eligibility Criteria

Inclusion Criteria

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

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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 or spinal cord metastases that haven't been treated.

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I don't have another cancer needing treatment or one active in the last 2 years.

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

6Treatment groups

Experimental Treatment

Group I: Part E: BMS-986442 + Nivolumab + Carboplatin + PaclitaxelExperimental Treatment4 Interventions

Group II: Part D: BMS-986442 + Nivolumab + Carboplatin + PemetrexedExperimental Treatment4 Interventions

Group III: Part C: BMS-986442 + Nivolumab + DocetaxelExperimental Treatment3 Interventions

Group IV: Part B2: BMS-986442 + NivolumabExperimental Treatment2 Interventions

Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Group V: Part B1: BMS-986442 + NivolumabExperimental Treatment2 Interventions

Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Group VI: Part A: BMS-986442 + NivolumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Nivolumab

2015

Completed Phase 3

~4010

Docetaxel

1995

Completed Phase 4

~6550

Carboplatin

2014

Completed Phase 3

~6120

0 / 3Eligibility 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 targeted therapies, immunotherapies, and chemotherapy. Targeted therapies inhibit specific molecular pathways essential for cancer cell growth, such as EGFR or ALK. Immunotherapies, like nivolumab, boost the immune system's ability to recognize and destroy cancer cells by blocking checkpoints like PD-1/PD-L1. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Understanding these mechanisms allows for personalized treatment plans, improving outcomes and minimizing side effects for NSCLC patients.

Update on recent key publications in lung oncology: picking up speed.Emerging therapeutic agents for lung cancer.Management of patients with lung cancer and poor performance status.