This phase II trial studies how well pembrolizumab works in treating patients with non-squamous non-small cell lung cancer which has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. To correlate circulating tumor DNA (ctDNA) levels measured using cancer personalized profiling by deep sequencing (CAPP-Seq) with radiographic tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with pembrolizumab. SECONDARY OBJECTIVES: I. To correlate PD-L1 assessment on pre-treatment tumor samples with objective response using RECIST v1.1 criteria in patients with metastatic non-squamous NSCLC treated with pembrolizumab. II. To determine the overall response rate (ORR) using RECIST v1.1 criteria in patients with metastatic non-squamous NSCLC treated with pembrolizumab. III. To determine the progression-free survival (PFS) using RECIST v1.1 in patients with metastatic non-squamous NSCLC treated with pembrolizumab. IV. To determine the overall survival (OS) in patients with metastatic non-squamous NSCLC treated with pembrolizumab. V. To determine the safety and tolerability of pembrolizumab in patients with metastatic non-squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Given IV, 200mg fixed dose, every 3 weeks
Stanford University, School of Medicine
Palo Alto, California, United States
Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments
Circulating tumor DNA (ctDNA) levels will be measured using Cancer personalized profiling by deep sequencing (CAPP Seq) with radiographic tumor assessments using RECIST v1.1 criteria in patients with metastatic NSCLC treated with pembrolizumab. ctDNA will be measured as percentage of total circulating free DNA. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 2 years
Overall Response Rate (ORR)
Overall Response Rate (ORR) defined as proportion of complete responses + partial responses will be measured using RECIST v1.1 criteria
Time frame: Up to 2 years
PFS Measured Using RECIST v1.1 Criteria
Progression-free survival (PFS) will be measured from the time of first treatment with pembrolizumab to the time of radiographic progression, unequivocal clinical progression, or death from any cause, whichever comes earlier
Time frame: From the time of first treatment with pembrolizumab to the time of progression or death from any cause, whichever comes earlier, assessed up to 2 years
Overall Survival (OS)
Overall Survival of all treated participants
Time frame: From the time of first treatment with pembrolizumab to the time of death, assessed up to 3 years
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.03
Time frame: Up to 2 years
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