Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byTina Cascone

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well nivolumab works when given alone and in combination with ipilimumab or chemotherapy in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, docetaxel, 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. Giving nivolumab with ipilimumab or chemotherapy may work better in treating patients with non-small cell lung cancer compared to chemotherapy alone.

Eligibility Criteria

This trial is for patients with untreated stage I-IIIA non-small cell lung cancer who are suitable for surgery, have good organ function and performance status (able to carry out daily activities), and can provide consent. They must not be pregnant, on current cancer therapy, or have severe allergies to monoclonal antibodies or certain chemotherapy drugs.

Inclusion Criteria

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

My lung cancer diagnosis was confirmed through lab tests and has not been treated yet.

My cancer is at stage IB (>=4 cm), IIA, IIB, or IIIA.

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Exclusion Criteria

I am currently undergoing cancer treatment or participating in a drug trial.

I have hearing loss as confirmed by an audiologist.

You have a current or suspected autoimmune disease.

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Treatment Details

Interventions

Carboplatin (Alkylating agents)
Cisplatin (Alkylating agents)
Docetaxel (Anti-tumor antibiotic)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)
Pemetrexed (Anti-metabolites)

Trial OverviewThe study tests how well nivolumab works alone or combined with ipilimumab or chemotherapy (cisplatin, docetaxel, pemetrexed) in treating these lung cancer patients. It compares the effectiveness of immunotherapy versus traditional chemotherapy in stopping tumor growth.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Arm D (ipilimumab, nivolumab, chemotherapy)Experimental Treatment6 Interventions

Patients receive ipilimumab IV over 90 minutes on day 1, nivolumab IV over 30 minutes on days 1, 22, and 43, and cisplatin (or carboplatin) IV over 2 hours on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour or pemetrexed IV over 10 minutes on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (nivolumab, cisplatin, docetaxel, pemetrexed)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes and cisplatin IV over 2 hours on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour or pemetrexed IV over 10 minutes on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (nivolumab, ipilimumab)Experimental Treatment2 Interventions

Participants receive nivolumab as in Arm A and receive ipilimumab IV over 90 minutes on day 1 in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (nivolumab)Experimental Treatment1 Intervention

Participants receive nivolumab IV over 60 minutes on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Paraplatin for: