A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed cell death receptor ligand 1 (PD-L1) positive.
Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. Osimertinib will be the sequential treatment strategy at progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks.
Osimertinib will be the sequential treatment strategy at progression until resistance develops.
Peking Union Medical College Hospital
Beijing, China
progression free survival 1 (PFS1)
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
Time frame: up to 8 weeks
progression free survival 2 (PFS2)
the time length from enrollment to any of the following events: disease progression with Osimertinib or death from any cause. Disease progression will be assessed according to RECIST 1.1
Time frame: up to 8weeks
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0
Time frame: up to 8 weeks
objective response rate (ORR)
Proportion of patients with Complete and Partial Responses to first-line therapy.
Time frame: up to 8 weeks
Life quality score
Evaluate life quality score according to Karnofsky performance status (KPS). On a scale of 10, higher scores indicate better health. A score of 0 is defined as death, on a 100-point scale, indicating normal physical fitness with no obvious symptoms and signs.
Time frame: up to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.