Erlotinib + Cabozantinib for Non-Small Cell Lung Cancer

Palo Alto (17 mi)

Overseen byJoel W Neal

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

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.

Eligibility Criteria

This trial is for adults with Stage IV non-small cell lung cancer who have a specific mutation in the EGFR gene, have received 1-2 prior chemotherapy treatments, and can swallow tablets. They should not have had certain previous cancer therapies or major health issues that could affect their participation.

Inclusion Criteria

My tumor has a specific change in the EGFR gene.

I can take care of myself and am up and about more than half of my waking hours.

I have enough cancer tissue samples for MET testing.

My cancer has grown after at least 2 treatment rounds.

I have had 1 or 2 rounds of chemotherapy.

My lung cancer is at stage IV.

Exclusion Criteria

I am HIV positive and on antiretroviral therapy.

I have been diagnosed with chronic active hepatitis B.

I am currently taking certain medications.

I have had cancer within the last 2 years that needed or still needs treatment.

I do not have any severe, uncontrolled illnesses.

I have previously received treatments targeting specific cancer growth factors.

Treatment Details

The study is testing how well erlotinib hydrochloride and cabozantinib-s-malate work alone or together as second or third line therapy for patients. These drugs block enzymes needed by tumor cells to grow, but it's unclear if combining them offers better results.

4Treatment groups

Experimental Treatment

Group I: Arm Z (erlotinib+cabozantinib; step II)Experimental Treatment3 Interventions

Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (erlotinib+cabozantinib)Experimental Treatment3 Interventions

Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (cabozantinib)Experimental Treatment2 Interventions

Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (erlotinib)Experimental Treatment2 Interventions

Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cabozantinib S-malate is already approved in United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as Cabometyx for: