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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 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
~5370
Nivolumab
2014
Completed Phase 3
~5220
Docetaxel
1995
Completed Phase 4
~6550
Carboplatin
2014
Completed Phase 3
~6120

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.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,948 Total Patients Enrolled

Media Library

BMS-986442 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05543629 — Phase 1 & 2
Lung Cancer Research Study Groups: Part A: BMS-986442 + Nivolumab, Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel, Part B1: BMS-986442 + Nivolumab, Part B2: BMS-986442 + Nivolumab, Part C: BMS-986442 + Nivolumab + Docetaxel, Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
Lung Cancer Clinical Trial 2023: BMS-986442 Highlights & Side Effects. Trial Name: NCT05543629 — Phase 1 & 2
BMS-986442 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543629 — Phase 1 & 2
~12 spots leftby Nov 2025