Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors

Sponsor
Hunan Province Tumor Hospital
Study ID
NCT05055908
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed plus Pembrolizumab — DRUG
    Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
  • Pembrolizumab — DRUG
    Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
  • Pemetrexed — DRUG
    Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.

Study Details

The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Key Dates

Start date
Oct 1, 2021
Status verified
Jul 2024
Primary completion
Jul 1, 2025
Completion
Sep 14, 2027

Study Design

Enrollment
12,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors
    Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
  • Experimental: Cohort B: Immune Checkpoint Inhibitors monotherapy
    Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.
  • Experimental: Cohort C: Chemotherapy Group.
    Lung Cancer patients treated with Chemotherapy.

Primary Outcome Measure

Correlation between Adverse events (AEs) and gene profile [ Time Frame: Time from first subject dose to study completion, or up to 36 month ]

Central Contacts

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