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ALK Inhibitor

Brigatinib + Carboplatin + Pemetrexed for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Yasir Y Elamin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
2. Documented ALK re-arrangement as detected by: (1) FISH, (2) IHC, (3) tissue NGS, or (4) cfDNA NGS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.

Who is the study for?
This trial is for individuals with advanced non-small cell lung cancer that tests positive for a change in the ALK gene. Participants should not have received brigatinib previously and must be fit enough for chemotherapy or local treatments like radiotherapy or surgery.
What is being tested?
The study is testing whether taking brigatinib along with either local consolidation therapy (like radiation or surgery) or chemotherapy drugs pemetrexed and carboplatin can better control lung cancer than just brigatinib alone.
What are the potential side effects?
Possible side effects include nausea, fatigue, high blood pressure, vision changes from brigatinib; numbness, kidney issues from pemetrexed; and hair loss, low blood counts from carboplatin.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

3Treatment groups
Experimental Treatment
Group I: Brigatinib MonotherapyExperimental Treatment1 Intervention
Given by mouth
Group II: Brigatinib + Local Consolidation Therapy (LCT)Experimental Treatment1 Intervention
Given by vein
Group III: Brigatinib + Carboplatin + PemetrexedExperimental Treatment3 Interventions
Given by vein
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
2018
Completed Phase 3
~890
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,079 Total Patients Enrolled
Yasir Y Elamin, MDPrincipal InvestigatorMD Anderson Cancer Cetner
2 Previous Clinical Trials
49 Total Patients Enrolled
~112 spots leftby Dec 2029
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