Active — Not RecruitingPhase 3

Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

United States600 participantsStarted 2019-04-05

Plain-language summary

This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. 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. Chemotherapy drugs, such as 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. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer (NSCLC) (includes M1a, M1b, and M1c stage disease, American Joint Committee on Cancer \[AJCC\] 8th edition). Patients with stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation. Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed * Patients must have PD-L1 expression Tumor Proportion Score (TPS) \>= 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patients are not eligible. The assay must have been performed by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory * Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration * NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids * NOTE: An additional 15 days is allowed to account for any infection/exposure related logistical delays * Patients must be \>= 18 years of age * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Patients must NOT have received the following: * Prior systemic chemotherapy…

What they're measuring

Overall survival (OS)

Timeframe: From randomization to death from any cause, assessed up to 5 years post treatment

Trial details

NCT IDNCT03793179

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-09-30