SWOG clinical trial number
S2302

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

Open
Phase
Accrual
94%
Abbreviated Title
PRAGMATICA - LUNG
Status Notes
March 6, 2023: S2302 is open to accrual.

SWOG has partnered with Matthews Media Group (MMG) to help us increase and diversify enrollment to this trial. They may contact your site directly to offer support or ask about potential barriers.
Activated
03/06/2023

Research committees

Lung Cancer

Treatment

MK-3475 Ramucirumab

Eligibility Criteria Expand/Collapse

Non-small cell lung cancer (NSCLC) which is Stage IV or recurrent.

At least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC.

More than one line of anti-PD-1 or anti-PD-L1 for Stage IV or recurrent disease.

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 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 not be receiving or planning to receive another investigational therapy during study participation.

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 described in Section 7.2, per the current FDA-approved package insert(s), treating investigator’s discretion, and institutional guidelines.

Participants must have Zubrod Performance Status of 0-2 (see Section 10.3).

Publication Information Expand/Collapse

2024

Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302)

D Carrizosa;J Miao;K Reckamp;K Dragnev;P Hesketh;W Iams;B Henick;C Czerlanis;F DeSanto;J Sundstrom;J Johnson;L Gansauer;T Groller;M Redman;R Herbst;J Gray ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), poster; J Clin Oncol 42, 2024 (suppl 16; abstr 11019)

SWOG S2302, PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab plus Pembrolizumab (PR) versus Standard of Care (SOC) for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

K Reckamp;M Redman;K Dragnev;W Iams;B Henick;J Miao;D Carrizosa;RS Herbst;J Gray ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), TIP, poster; J Clin Oncol 42, 2024 (suppl 16; abstr TPS8657)

Pragmaticism in Cancer Clinical Trials [Review]

K Sankar;M Redman;K Dragnev;B Henick;W Iams;C Blanke;R Herbst;J Gray;K Reckamp ASCO Educational Book Jun;44(3):e100040

PMid: PMID: 38771997

Project Pragmatica: S2302 Pragmatica-Lung and its Application in rare cancers

K Dragnev;M Redman;D Carrizosa;B Henick;M Khalil;C Blanke;R Herbst;K Reckamp;JE Gray Korean Society of Medical Oncology Meeting (September 26 to 27, 2024.Seoul, Korea)

Reports & Approvals

Trial Locations