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
63%
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.
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
Other Study Materials
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).
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).
Other Clinical Trials
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
Research Committee(s)
Lung Cancer
Activated
03/06/2023
Accrual
63%
Open
Phase
SWOG Clinical Trial Number
A082002
A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer
Research Committee(s)
Lung Cancer
Activated
12/21/2021
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-LU007
RAndomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Research Committee(s)
Lung Cancer
Activated
08/17/2020
Open