Pembrolizumab + Olaparib/Pemetrexed for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+177 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is comparing two treatment combinations for a specific type of lung cancer. It aims to find out which combination helps patients live longer and keeps their cancer from getting worse. The treatments work by boosting the immune system, making it harder for cancer cells to repair themselves, or stopping their growth.

Eligibility Criteria

This trial is for adults with stage IV nonsquamous NSCLC who haven't had prior treatments. They must have a life expectancy of at least 3 months, be able to use contraception, and not be pregnant. Participants need good organ function and no severe allergies to the drugs being tested or their ingredients.

Inclusion Criteria

I haven't had systemic treatment for my advanced lung cancer.

My lung cancer is advanced (stage IV) and not squamous.

I have provided a biopsy sample of my tumor that has not been treated with radiation.

My lung cancer is not squamous cell type.

My cancer is not suitable for EGFR, ALK, or ROS1 treatments.

Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

My lung cancer is mainly squamous cell type.

I have been diagnosed with MDS/AML or my condition suggests I might have it.

I have another cancer that has worsened in the last 3 years and needs treatment.

I have been treated with drugs targeting PD-L1, PD-L2, or T-cell receptors.

I haven't had palliative radiotherapy in the last week and have no side effects needing steroids.

I have been treated with olaparib or another PARP inhibitor before.

I have lung disease or needed steroids for lung inflammation.

I have an immune system disorder or am on long-term steroids.

I have cancer that has spread to my brain or spinal cord.

I have a history of HIV, hepatitis B, or active hepatitis C.

Participant Groups

The study compares two treatments: pembrolizumab combined with olaparib versus pembrolizumab with pemetrexed after initial therapy. It aims to see which combination is better for extending patients' lives without cancer progression and overall survival.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Pemetrexed + Platinum Therapy + OlaparibExperimental Treatment5 Interventions

For the Induction Phase, participants receive 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. The participant can continue to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).

Group II: Pembrolizumab + Pemetrexed + Platinum Therapy + PemetrexedActive Control4 Interventions

For the Induction Phase, participants receive 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg IV on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin AUC 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. The participant can continue to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: