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Clinical Trials in Mexico / NCT05633602
Active, not recruiting Phase 3

Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

NCT05633602 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2023-03-14
Last updated
2026-04-17

Condition(s) studied

Recurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8

Investigational drug(s) / intervention(s)

ChemotherapyPembrolizumab →Ramucirumab →

Chemotherapy: Receive standard of care chemotherapy

Pembrolizumab: Given IV

Ramucirumab: Given IV

Study summary

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. 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 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is stage IV or recurrent * Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy * Participants must have experienced disease progression (in the opinion of the treating physician) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 therapy * Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable, partial response or complete response (in the opinion of the treating physician) * Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have experienced disease progression within (=\<) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or PD-L1 therapy * Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating physician) during or after this regimen * Participants with a known sensitizing mutation for which an Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met * Participants must be \>= 18 years old * Participants must be able to safely receive the investigational drug combination and the investigator's choice of standard of care regimens per the current FDA approved package insert(s), treating investigator's discretion, and institutional guidelines * Participants must have Zubrod performance status of 0-2 Exclusion Criteria: * Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for stage IV or recurrent disease * Participants must not be receiving or planning to receive another investigational therapy during study participation

Primary outcome measure(s)

Trial sites (566)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
University of South Alabama Mitchell Cancer Institute Mobile Alabama
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Highlands Oncology Group - Fayetteville Fayetteville Arkansas
Mercy Hospital Fort Smith Fort Smith Arkansas
John L McClellan Memorial Veterans Hospital Little Rock Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Highlands Oncology Group - Rogers Rogers Arkansas
Highlands Oncology Group Springdale Arkansas
Kaiser Permanente-Anaheim Anaheim California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Tower Cancer Research Foundation Beverly Hills California
Marshall Cancer Center Cameron Park California
City of Hope Comprehensive Cancer Center Duarte California
Kaiser Permanente Dublin Dublin California
Kaiser Permanente-Fontana Fontana California
Kaiser Permanente-Fremont Fremont California
Palo Alto Medical Foundation-Fremont Fremont California
Kaiser Permanente - Harbor City Harbor City California
City of Hope at Huntington Beach Huntington Beach California
City of Hope at Irvine Lennar Irvine California
Kaiser Permanente-Irvine Irvine California
City of Hope Antelope Valley Lancaster California
Loma Linda University Medical Center Loma Linda California
City of Hope at Long Beach Elm Long Beach California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Cedars Sinai Medical Center Los Angeles California
Fremont - Rideout Cancer Center Marysville California
Memorial Medical Center Modesto California
Kaiser Permanente-Modesto Modesto California
City of Hope Newport Beach Newport Beach California
Kaiser Permanente-Oakland Oakland California
Kaiser Permanente-Ontario Ontario California
Palo Alto Medical Foundation Health Care Palo Alto California

+ 526 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More SWOG Cancer Research Network trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05633602 on ClinicalTrials.gov ↗ ← All trials in Mexico