Combination Therapy for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Yasir Y Elamin | MD Anderson Cancer Center

Overseen byYasir Y. Elamin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage IIIC or IV, or has come back (recurrent). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving ensartinib, carboplatin, pemetrexed and bevacizumab may help to control the disease.

Eligibility Criteria

Adults with ALK-positive non-small cell lung cancer at stage IIIC, IV, or recurrent who can swallow pills and have a life expectancy of over 12 weeks. They may be treatment-naive or have had prior treatments but must meet specific blood count and organ function criteria. Pregnant women, those with recent serious heart issues, other cancers within 2 years (except certain skin/cervical cancers), active infections, or severe medical conditions are excluded.

Inclusion Criteria

I can swallow and keep down pills.

My blood clotting time is normal or managed if I'm on blood thinners.

You are expected to live for at least 12 more weeks.

+15 more

Exclusion Criteria

You are allergic to the dye used in the ensartinib 100 mg capsule.

I haven't had cancer in the last 2 years, except for certain skin cancers, cervical cancers, or any cured cancer.

I haven't had serious heart or stroke issues in the last 6 months.

+12 more

Participant Groups

The trial is testing the combination of Ensartinib (a growth-blocking enzyme inhibitor) with Carboplatin and Pemetrexed (chemotherapy drugs), plus Bevacizumab (a monoclonal antibody that hinders tumor spread). The goal is to find the optimal dose of Ensartinib and assess its effectiveness alongside these drugs in controlling advanced lung cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (ensartinib, carboplatin, pemetrexed, bevacizumab)Experimental Treatment4 Interventions

INDUCTION THERAPY: Patients receive ensartinib PO QD on days 1-21, carboplatin IV over 15-60 minutes on day 1, pemetrexed IV over 10 minutes on day 1 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ensartinib 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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺 Approved in European Union as Avastin for: