Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)
A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Sponsor: SWOG Cancer Research Network + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS) (Comparison between arms)
Time frame: From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years
PFS (Comparison between arms)
Time frame: From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years
Response rate of SG against historical response rates (Single arm evaluation)
Time frame: Up to 3 years
Response rate of I against historical response rates (Single arm evaluation)
Time frame: Up to 3 years
Secondary Endpoints
Rate of dose-limiting toxicities among participants treated with SG-I in the safety run-in analysis population
Response rates
Response rates
Eligibility Criteria
Inclusion Criteria: * Participants must have been assigned to S1900N by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900N is determined by submission of documentation of NSCLC harboring an actionable genomic alteration (AGA) in the LUNGMAP protocol. AGA is defined in this protocol as an activating driver alteration with an approved targeted therapy for lung cancer in one of the following genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. * Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be …
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