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Ramucirumab + Pembrolizumab vs Chemotherapy for Non-Small Cell Lung Cancer
Study Summary
This trial compares ramucirumab+pembrolizumab vs chemo for non-small cell lung cancer. Ramucirumab+pembrolizumab may stop tumors from growing and spreading, while chemo kills/stops cells from dividing/spreading. Results may help find out if this combo is more effective than chemo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I had a positive response to previous immunotherapy for my advanced or recurrent cancer.My cancer worsened within a year after starting anti-PD-1 or PD-L1 therapy.My cancer worsened more than 84 days after starting my last anti-PD-1 or PD-L1 therapy.I have a specific mutation in my lung cancer and have tried at least one FDA-approved targeted therapy.I have not had more than one type of immunotherapy for my advanced or recurrent cancer.My cancer progressed after or during platinum-based chemotherapy.My lung cancer is confirmed to be stage IV or has come back.I can take care of myself and am up and about more than 50% of my waking hours.I am 18 years old or older.I can safely receive the trial drugs according to the FDA and my doctor's advice.I have been treated with anti-PD-1 or anti-PD-L1 therapy for lung cancer.
- Group 1: ARM A (standard of care chemotherapy)
- Group 2: ARM B (ramucirumab, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current population size participating in this research endeavor?
"To adequately assess the efficacy of this medical intervention, a cohort of 700 patients must be recruited. Those that meet the pre-determined criteria can participate at either Kaiser Permanente Dublin in Dublin, Connecticut or Kaiser Permanente Fremont in Fremont, Delaware."
Is the research team still accepting volunteers for this experiment?
"According to clinicaltrials.gov, the recruitment process for this medical trial is still ongoing and was initiated on March 6th 2023 with a most recent update posted on April 14th of the same year."
Has the FDA sanctioned ARM B (ramucirumab, pembrolizumab) for clinical use?
"Our team's assessment of the safety profile for ARM B (ramucirumab, pembrolizumab) is a 3 due to its Phase 3 trial status. This indicates there are multiple instances of evidence in support of both efficacy and security."
How many medical institutions are facilitating this trial?
"The clinical trial encompasses 76 sites, including the Kaiser Permanente Dublin in Dublin and the Kaiser Permanente-Fremont in Fremont. Other locations that are participating include the Kaiser Permanente-Modesto in Modesto."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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