Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04203485
Phase
PHASE3
Status
Unknown

Conditions

  • PD-L1 Positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab 200mg — BIOLOGICAL
    Camrelizumab 200mg q2w ivgtt
  • Apatinib Mesylate 250mg — DRUG
    Apatinib Mesylate 250mg po qd
  • Pemetrexed disodium for injection — DRUG
    Pemetrexed disodium for injection 500 mg/m2 q3w
  • Paclitaxel injection — DRUG
    Paclitaxel injection 175 mg/m2 q3w
  • Carboplatin — DRUG
    Carboplatin AUC 5 mg/mL/min q3w

Study Details

The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.

Key Dates

Start date
Jun 15, 2020
Status verified
May 2020
Primary completion
Mar 31, 2022
Completion
May 31, 2022

Study Design

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

Arms

  • Experimental: Camrelizumab 200mg + Apatinib Mesylate 250mg
    Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
  • Experimental: Camrelizumab 200mg
    Camrelizumab 200mg q2w ivgtt
  • Active Comparator: Pemetrexed/Paclitaxel injection+ Carboplatin
    For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin

Primary Outcome Measure

Progression Free Survival (PFS) assessed by Independent review committee (IRC) [ Time Frame: up to 2 years ]

Central Contacts