BMS-986442 for Non-small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ
Non-small Cell Lung Cancer+3 More
BMS-986442 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Eligible Conditions

  • Non-small Cell Lung Cancer
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: At 6 months and 12 months

Month 12
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
Progression-free Survival Rate (PFSR)
Up to 119 Weeks
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Incidence of AEs leading to death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Incidence of Adverse Events (AEs)
Incidence of Anti-drug Antibodies (ADAs) to BMS-986442
Incidence of Serious Adverse Events (SAEs)
Maximum observed plasma concentration (Cmax)
Time of maximum observed concentration (Tmax)

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Part A: BMS-986442 + Nivolumab
1 of 6
Part B2: BMS-986442 + Nivolumab
1 of 6
Part C: BMS-986442 + Nivolumab + Docetaxel
1 of 6
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
1 of 6
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
1 of 6
Part B1: BMS-986442 + Nivolumab
1 of 6
Experimental Treatment

225 Total Participants · 6 Treatment Groups

Primary Treatment: BMS-986442 · No Placebo Group · Phase 1 & 2

Part A: BMS-986442 + NivolumabExperimental Group · 2 Interventions: BMS-986442, Nivolumab · Intervention Types: Biological, Biological
Part B2: BMS-986442 + NivolumabExperimental Group · 2 Interventions: BMS-986442, Nivolumab · Intervention Types: Biological, Biological
Part C: BMS-986442 + Nivolumab + DocetaxelExperimental Group · 3 Interventions: Docetaxel, BMS-986442, Nivolumab · Intervention Types: Drug, Biological, Biological
Part D: BMS-986442 + Nivolumab + Carboplatin + PemetrexedExperimental Group · 4 Interventions: BMS-986442, Nivolumab, Pemexetred, Carboplatin · Intervention Types: Biological, Biological, Drug, Drug
Part E: BMS-986442 + Nivolumab + Carboplatin + PaclitaxelExperimental Group · 4 Interventions: BMS-986442, Nivolumab, Carboplatin, Paclitaxel · Intervention Types: Biological, Biological, Drug, Drug
Part B1: BMS-986442 + NivolumabExperimental Group · 2 Interventions: BMS-986442, Nivolumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~8840
Nivolumab
2014
Completed Phase 3
~5540
Carboplatin
2014
Completed Phase 3
~6570
Paclitaxel
2011
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months and 12 months
Closest Location: John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, NJ
Photo of Hackensack 1Photo of Hackensack 2Photo of Hackensack 3
2017First Recorded Clinical Trial
2 TrialsResearching Non-small Cell Lung Cancer
48 CompletedClinical Trials

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,463 Previous Clinical Trials
3,907,679 Total Patients Enrolled
22 Trials studying Non-small Cell Lung Cancer
3,429 Patients Enrolled for Non-small Cell Lung Cancer

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have measurable disease per RECIST v1.1.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You must be aged at least 3 months at the time of first dose.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.