Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+524 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, 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 pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

Eligibility Criteria

This trial is for patients aged 70 or older with advanced non-small cell lung cancer that has returned and spread. Participants must have proper organ function, no untreated brain metastases, be off corticosteroids, speak English to complete questionnaires, and not plan other cancer treatments within 3 months of joining.

Inclusion Criteria

Your bilirubin level in the blood is within a certain range, unless you have Gilbert's disease, in which case it can be slightly higher.

I have no cancer treatments planned for the next 3 months.

Your platelet count is at least 100,000 per cubic millimeter.

+11 more

Participant Groups

The study tests pembrolizumab (an immunotherapy drug) alone or combined with chemotherapy drugs pemetrexed and carboplatin in elderly patients. It aims to see if these treatments can shrink tumors by helping the immune system attack the cancer or by stopping tumor growth.

2Treatment groups

Experimental Treatment

Group I: Group B (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Group A (pembrolizumab)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days 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: