IRB Study Number 22-1390
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective
To estimate co-occurring genomic alterations (e.g. TP53, STK11, KEAP1, etc.) as well as associated rates of ctDNA detection and clearance in patients with KRAS-mutated NSCLC who are treated with second-line KRAS-directed therapy.
Secondary Objectives
Include the correlation between co-occurring genomic alterations (e.g. TP53, STK11, KEAP1, etc.) and ctDNA clearance rate, objective response rates (as determined by RECIST version 1.1 evaluation), progression free survival, overall survival, and drug-related adverse events in the study population.
Inclusion Criteria
Patients aged 18 years or older with metastatic lung adenocarcinoma that harbor a KRAS mutation within the Cleveland Clinic health care system AND
Have had disease progression after at least one line of systemic treatment with standard chemotherapy and/or checkpoint inhibitor therapy AND
Are expected to begin next-line treatment with KRAS-directed therapy.
Exclusion Criteria
Patients with metastatic lung adenocarcinoma that DOES NOT harbor a KRAS mutation
Patients currently receiving systemic therapy not specifically targeting KRAS who have stable disease
Patients currently receiving treatment with KRAS-directed therapy
Patients who have had disease progression while participating in a clinical trial using another form of KRAS-directed treatment
