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

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chemotherapy — DRUG
  Receive standard of care chemotherapy
• Pembrolizumab — BIOLOGICAL
  Given IV
• Ramucirumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Mar 14, 2023

Status verified

Apr 2026

Primary completion

Nov 26, 2025

Completion

Mar 15, 2028

Study Design

Enrollment

838 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ARM A (standard of care chemotherapy)
  Patients receive chemotherapy per standard of care on study.
• Experimental: ARM B (ramucirumab, pembrolizumab)
  Patients receive ramucirumab IV and pembrolizumab IV on study.

Primary Outcome Measure

Overall survival [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 3 years ]

Locations (566)

Related coverage on Hipa.ai

• Pembrolizumab Trial for NSCLC Scheduled for Primary Completion in November 2025
  Pembrolizumab · Nov 26, 2025 · ClinicalTrials.gov

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