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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
Select...
My lung cancer is confirmed to be stage IV or has come back.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
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
~2010
Ramucirumab
2017
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,111 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,215,899 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,446 Total Patients Enrolled

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05633602 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: ARM A (standard of care chemotherapy), ARM B (ramucirumab, pembrolizumab)
Non-Small Cell Lung Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT05633602 — Phase 3
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633602 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Loma Linda University Medical Center
UPMC Camp Hill
University of South Alabama Mitchell Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
2023. "Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633602.
All > Lung Cancer Dallas > Honolulu
~292 spots leftby Mar 2025
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