Fluzoparib Combined With Camrelizumab for Maintenance Treatment of Locally Advanced Non-small Cell Lung Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04828395
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — BIOLOGICAL
    200mg iv Q3W
  • Fluzoparib — DRUG
    150mg bid
  • Cisplatin，Pemetrexed — DRUG
    Cisplatin 75mg/m2 IV and Pemetrexed 500mg/m2 IV Q3W (Day 1 of each cycle of cycles 1-3) (non-squamous cell carcinoma only)
  • Cisplatin，Etoposide — DRUG
    Cisplatin 50mg/m2 IV (the 1st and 8th days of the 1st cycle and the 2nd cycle; the 8th and 15th days of the 3rd cycle); Etoposide 50mg/m2 IV (the 1st cycle And the 1st to the 5th day of the 2nd cycle; the 8th to the 12th day of the 3rd cycle).
  • Carboplatin, Albumin Paclitaxel — DRUG
    Carboplatin AUC=6, Albumin Paclitaxel 100mg/m2 IV; Days 1, 8 and 15 of cycles 1, 2, and 3.
  • Radiotherapy — RADIATION
    60 Gy (total 6 weeks)

Study Details

Fluzoparib combined with Camrelizumab for maintenance treatment of locally advanced non-small cell lung cancer after concurrent radiotherapy and chemotherapy

Key Dates

Start date
Mar 1, 2021
Status verified
Mar 2021
Primary completion
Mar 1, 2023
Completion
Mar 1, 2025

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review [ Time Frame: 2 year ]

Central Contacts

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