Osimertinib + Ramucirumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byXiuning Le, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Xiuning Le

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

Research Team

Xiuning Le, MD PhD

Principal Investigator

MD Anderson

Eligibility Criteria

Adults with non-squamous, non-small cell lung cancer (NSCLC) that has specific EGFR mutations and is advanced or metastatic. Participants must be able to swallow pills, have good organ function, no significant bleeding risks or recent serious blood clots, and not have had certain other cancers in the last 2 years. They should not have used drugs like osimertinib before and need to use contraception if of childbearing potential.

Inclusion Criteria

Your platelet count should be at least 100,000 per cubic millimeter.

My brain metastases are stable, treated, or symptom-free, and I'm on low or no steroids.

Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

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Exclusion Criteria

I have had a GI perforation or am at risk for one in the last 6 months.

My high blood pressure has not been controlled with medication for over 4 weeks.

I have had severe GI bleeding in the last 3 months.

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Treatment Details

Interventions

Osimertinib (Tyrosine Kinase Inhibitor)
Ramucirumab (Monoclonal Antibodies)

Trial OverviewThe trial tests whether adding Ramucirumab to Osimertinib improves progression-free survival compared to using Osimertinib alone in NSCLC patients. Progression-free survival means how long patients live without their disease getting worse. The study randomly assigns participants into two groups following a 2:1 ratio favoring the combination treatment.

Participant Groups

2Treatment groups

Active Control

Group I: Arm B (Osimertinib)Active Control1 Intervention

Osimertinib

Group II: Arm A (Osimertinib and Ramucirumab)Active Control2 Interventions

Osimertinib and Ramucirumab