Chemotherapy Combines With Bevacizumab and PD-1 Inhibitor in Non-squamous NSCLC

Sponsor
Qingdao Central Hospital
Study ID
NCT05267366
Phase
PHASE2
Status
Unknown

Conditions

  • OS
  • PFS

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. PD-1 inhibitor plus chemotherapy showed prolonged survival in NSCLC by the study of KEYNOTE 024, KEYNOTE 189 etc. Thus, this study combines immunotherapeutic agent PD-1 inhibitor with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin/cisplatin and pemetrexed).

Key Dates

First listed
Mar 4, 2022
Start date
Feb 1, 2022
Status verified
Mar 2023
Primary completion
Feb 1, 2024
Completion
Jul 1, 2024

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemothreapy with PD-1 inhibitor and bevacizumab
    PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 Bevacizumab 15 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Bevacizumab 15mg/m2, iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years.
  • Active Comparator: Chemothreapy with PD-1 inhibitor
    PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years.

Primary Outcome Measure

Progression-free survival [ Time Frame: up to 24 months ]