Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
A observational or N/A phase clinical study on Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, this trial is ongoing. The trial is conducted by Eli Lilly and Company and has accumulated 14 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)PRIMARY OBJECTIVE:
I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
SECONDARY OBJECTIVE:
I. To summarize reports of serious and unexpected high-grade (\>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive chemotherapy per standard of care on study.
ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
PRIMARY OBJECTIVE:
I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
SECONDARY OBJECTIVE:
I. To summarize reports of serious and unexpected high-grade (\>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive chemotherapy per standard of care on study.
ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
Status Flow
Change History
14 versions recorded-
Apr 18, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE3 → None
-
Sep 2025 — Apr 2026 [monthly]
Active Not Recruiting PHASE3
-
Jun 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
-
Apr 2025 — Jun 2025 [monthly]
Recruiting PHASE3
-
Sep 2024 — Apr 2025 [monthly]
Recruiting PHASE3
▶ Show 9 earlier versions
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Mar 2024 — Jul 2024 [monthly]
Recruiting PHASE3
-
Oct 2023 — Mar 2024 [monthly]
Recruiting PHASE3
-
Jun 2023 — Oct 2023 [monthly]
Recruiting PHASE3
-
May 2023 — Jun 2023 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Apr 2023 — May 2023 [monthly]
Not Yet Recruiting PHASE3
-
Feb 2023 — Apr 2023 [monthly]
Not Yet Recruiting PHASE3
-
Jan 2023 — Feb 2023 [monthly]
Not Yet Recruiting PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Eli Lilly and Company
- Merck Sharp & Dohme LLC
- National Cancer Institute (NCI)
- SWOG Cancer Research Network
For direct contact, visit the study record on ClinicalTrials.gov .