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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
No Placebo-Only Group
Pivotal Trial

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 below
Select...
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 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

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

Awards & Highlights

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.

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 3
~3150
Ramucirumab
2017
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,501 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,677 Previous Clinical Trials
3,464,931 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,022 Previous Clinical Trials
5,186,470 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
~87 spots leftby Mar 2025
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