Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC

Sponsor
Sun Yat-sen University
Study ID
NCT04211090
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Metastases
  • Non-squamous Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
  • Pemetrexed — DRUG
    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
  • Carboplatin — DRUG
    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

Study Details

The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity

Key Dates

Start date
Jan 15, 2020
Status verified
Nov 2022
Primary completion
Aug 30, 2022
Completion
Dec 30, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab with pemetrexed / carboplatin
    Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer

Primary Outcome Measure

Intracranial Objective Response Rate (iORR) [ Time Frame: 1 year ]

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