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Only 6 spots left

~6 spots leftby Jun 2025

Cabozantinib + Nivolumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+706 other locations

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 trial is testing whether cabozantinib alone or with nivolumab is better than other treatments for patients with a type of lung cancer called non-squamous non-small cell lung cancer. Cabozantinib stops cancer cells from growing, while nivolumab helps the immune system fight the cancer. The goal is to see if these treatments can help patients live longer without their cancer getting worse.

Eligibility Criteria

This trial is for adults with non-squamous non-small cell lung cancer (NSCLC) who've had one round of platinum-based chemo and checkpoint inhibitor immunotherapy. They must have manageable side effects from past treatments, no major organ issues, can swallow pills, and have no severe heart conditions or untreated viral infections. Pregnant individuals or those planning to conceive are excluded.

Inclusion Criteria

My kidney function, measured by creatinine levels or clearance, is within the required range.

My cancer progressed after both platinum chemotherapy and immunotherapy.

I finished my last chemotherapy before the specified time.

I had hepatitis C but have been treated and cured.

My tumor does not have EGFR mutations or ALK rearrangements.

My lung cancer is non-squamous non-small cell type.

I have not had VEGFR-targeted therapy before.

My cancer has spread to distant parts of my body.

I have HIV, am on treatment, and my viral load is undetectable.

I have chosen a chemotherapy plan for my treatment and haven't used this chemotherapy for metastatic disease before.

My tumor does not have EGFR mutations or ALK rearrangements.

I have recovered from side effects of my previous treatment.

My heart function is classified as class 2B or better according to NYHA.

I am 18 years old or older.

I have no ongoing issues from previous radiation treatments.

I've had one round of chemotherapy and one round of immunotherapy for my cancer.

I am able to get out of my bed or chair and move around.

I have HIV, am on treatment, and my viral load is undetectable.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer has grown after at least 2 treatment cycles.

I have chronic hepatitis B but my viral load is undetectable.

Exclusion Criteria

I do not have any heart, blood vessel, or clotting disorders.

I do not have any serious stomach, gut, or infection issues.

My cancer has not spread to my brain or spinal cord.

I haven't had lung inflammation caused by drugs in the last 3 months.

I haven't had serious stomach or intestinal bleeding in the last 6 months.

I do not have an active or known history of autoimmune disease.

I haven't coughed up a significant amount of blood recently.

Participant Groups

The study tests if cabozantinib alone or combined with nivolumab is more effective than standard chemotherapy in NSCLC treatment. Cabozantinib blocks enzymes needed for tumor growth; nivolumab boosts the immune system's cancer fight. Standard chemo drugs kill or stop cancer cells from growing.

4Treatment groups

Experimental Treatment

Active Control

Group I: Step 2, Arm Z (cabozantinib S-malate, nivolumab)Experimental Treatment5 Interventions

Patients in Step 2, Arm Z receive cabozantinib S-malate PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group II: Step 1, Arm B (cabozantinib S-malate, nivolumab)Experimental Treatment5 Interventions

Patients in Step 1, Arm B receive cabozantinib S-malate PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group III: Step 1, Arm A (cabozantinib S-malate)Experimental Treatment4 Interventions

Patients in Step 1, Arm A receive cabozantinib S-malate PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group IV: Step 1, Arm C (standard chemotherapy)Active Control8 Interventions

Patients in Step 1, Arm C receive ramucirumab IV over 30-60 minutes and docetaxel IV over 1 hour on day 1, or docetaxel IV over 1 hour on days 1 and 8, or gemcitabine hydrochloride IV on days 1 and 8, or paclitaxel IV over 3 hours on day 1, or nab-paclitaxel IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity and at the discretion of the treating physician. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

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

🇺🇸 Approved in United States as Cabometyx for: