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Bi-functional Fusion Protein

Bintrafusp Alfa for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Xiuning Le
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This trial studies a combination of an immune-boosting drug, a growth-blocking drug, and chemotherapy in patients with advanced lung cancer that hasn't responded to other treatments. The goal is to help the immune system fight the cancer and stop it from growing and spreading.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Objective Response Rate (ORR) Within 6 Months
Progression Free Survival (PFS) at 18 Weeks
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Overall Survival (OS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (bintrafusp alfa, pemetrexed, carboplatin/cisplatin)Experimental Treatment4 Interventions
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Bintrafusp Alfa
2021
Completed Phase 2
~80
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,276 Total Patients Enrolled
Xiuning LePrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
203 Total Patients Enrolled
~1 spots leftby Sep 2025
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