Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients With Brain Metastases of Driven Gene-negative NSCLC

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT04768075
Phase
PHASE3
Status
Completed

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
  • Placebo — DRUG
    IV infusion Simulator of Camrelizumab
  • Cisplatin — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Pemetrexed — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Albumin paclitaxel — DRUG
    IV infusion

Study Details

This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of Camrelizumab + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT with placebo + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Key Dates

Start date
May 28, 2021
Status verified
May 2026
Primary completion
Mar 1, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab group
    subject will receive Camrelizumab intravenously(IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by Camrelizumab ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.
  • Placebo Comparator: placebo group
    subject will receive placebo intravenously (IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by placebo ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.

Primary Outcome Measure

Intracranial Progression-Free Survival(iPFS) [ Time Frame: up to 24 months ]

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