Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Overseen By Tina Cascone

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

101 Participants Needed

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.

Research Team

Tina Cascone

Principal Investigator

M.D. Anderson Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive nivolumab alone or in combination with ipilimumab or chemotherapy

6 weeks

3 visits (in-person)

Surgery

Surgical resection of the tumor is performed

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• Carboplatin
• Cisplatin
• Docetaxel
• Ipilimumab
• Nivolumab
• Pemetrexed

Trial Overview The 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

Group I: Arm D (ipilimumab, nivolumab, chemotherapy) Experimental Treatment 6 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 Treatment 4 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 Treatment 2 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 Treatment 1 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:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+