Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byXiuning Le

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Xiuning Le

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Age equal or greater than 18 years old and willing to give their signed consent

Histologically or cytologically confirmed non-squamous, non-small cell lung cancer

Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy

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Treatment Details

Interventions

Bintrafusp Alfa (Bi-functional Fusion Protein)
Carboplatin (Platinum-based Chemotherapy)
Cisplatin (Platinum-based Chemotherapy)
Pemetrexed (Antimetabolite)

Participant Groups

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.