NCT05392686

PD1 and PARP for Maintenance Therapy in NSLLC

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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."

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Tirelizumab
DRUG	PARP inhibitor	Fluzopari capsule

Timeline

• Start date: 2022-06-20
• Primary completion: 2022-06-21
• Completion: 2025-04-01
• First posted: 2022-05-26
• Last updated: 2022-05-26

Locations

1 site across 1 country: China