Lung Cancer Clinical Trial
Official title:
Single Arm, Single Center, Phase II Clinical Study of First-line in PD1 and PARP for Maintenance Therapy for Advanced Non-small Cell Lung Cancer (Lung Squamous Cell Carcinoma)
PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). Overall survival (OS).
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles ). In the Induction Phase, participants receive pd1 plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive PD1 plus maintenance PAPR. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance until centrally verified progressive disease (PD), intolerable toxicities, or physician decision." ;
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