Osimertinib +/− Bevacizumab for Lung Cancer with Brain Metastasis

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen bySarah B. Goldberg

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop or slow non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.

Eligibility Criteria

This trial is for adults with non-small cell lung cancer that has an EGFR mutation and spread to the brain. They should have a life expectancy over 3 months, be willing to use contraception, and not be breastfeeding or pregnant. No prior EGFR TKI treatment or immunotherapy is allowed, and they mustn't have symptomatic brain metastases or other active cancers.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My lung cancer has a specific change in the EGFR gene.

My cancer can be measured by scans or physical exams, but it's not a must.

+8 more

Exclusion Criteria

I have had lung conditions that needed steroid treatment.

You are allergic to Chinese hamster ovary cell products or other genetically engineered human antibodies.

I am allergic to osimertinib or similar drugs.

+21 more

Participant Groups

The study tests if osimertinib alone or combined with bevacizumab is more effective for patients whose lung cancer has spread to the brain. Osimertinib blocks enzymes needed by tumor cells; bevacizumab may prevent tumor growth by inhibiting blood vessel formation.

2Treatment groups

Experimental Treatment

Group I: Arm II (osimertinib)Experimental Treatment1 Intervention

Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Group II: Arm I (osimertinib, bevacizumab)Experimental Treatment6 Interventions

Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Osimertinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tagrisso for:

Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
Metastatic EGFR T790M mutation-positive NSCLC

🇪🇺 Approved in European Union as Tagrisso for:

Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
Metastatic EGFR T790M mutation-positive NSCLC