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Chemotherapy
Ramucirumab + Pembrolizumab vs Chemotherapy for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Led By Karen L Reckamp
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is stage IV or recurrent
Participants must have Zubrod performance status of 0-2
Must not have
Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for stage IV or recurrent disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer who've seen their disease progress after anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. They should have had a positive response to previous immunotherapy, be in fair health (Zubrod status 0-2), and able to receive the study drugs safely. Those with certain mutations must have tried FDA-approved targeted therapies.
What is being tested?
The Pragmatica-Lung Study is testing if combining ramucirumab (a drug that may stop blood vessel growth in tumors) with pembrolizumab (an immune system booster) works better than standard chemotherapy alone for advanced or returning non-small cell lung cancer.
What are the potential side effects?
Ramucirumab can cause high blood pressure, bleeding problems, and slow wound healing. Pembrolizumab might lead to an overactive immune system affecting organs, fatigue, skin reactions, and infusion-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be stage IV or has come back.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had more than one type of immunotherapy for my advanced or recurrent cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival
Secondary study objectives
Incidence of high-grade (>= grade 3) adverse events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ARM B (ramucirumab, pembrolizumab)Experimental Treatment2 Interventions
Patients receive ramucirumab IV and pembrolizumab IV on study.
Group II: ARM A (standard of care chemotherapy)Active Control1 Intervention
Patients receive chemotherapy per standard of care on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,487 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,220,944 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,283 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A (standard of care chemotherapy)
- Group 2: ARM B (ramucirumab, pembrolizumab)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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