Non-Chemotherapy Treatment (Ramucirumab plus Pembrolizumab) or Standard Chemotherapy for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Trial

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05633602
Trial Phases:	Phase III	Protocol IDs:	S2302 (primary) S2302 NCI-2022-09319
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	SWOG
NCI Full Details:	http://clinicaltrials.gov/show/NCT05633602

Summary

This phase III trial compares the effect of the combination therapy with 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 combination therapy with ramucirumab and pembrolizumab could help patients with stage IV or recurrent non-small cell lung cancer live longer compared to standard chemotherapy.

Objectives

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.
II. To compare OS between the arms within key subgroups.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive standard-of-care chemotherapy per investigator's choice based on Food and Drug Administration (FDA)-approved package insert(s).

ARM B: Patients receive ramucirumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and pembrolizumab IV over 30 minutes on day 1 for up to 35 cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed up every 3 months until death or 3 years after randomization, whichever occurs first.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

Barry D. Luskey MD

Lester E. Robertson MD, FACP

Mark A. Taylor MD

Grant C. Lewis MD

Ronald Goldberg MD

Alison Spellman MD

Gary W. Thomas MD

Majd Chahin MD

Stephen Andrew White M.D.

Gregory M. Haidemenos MD

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.