Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors
BECOME
1 other identifier
interventional
12,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Oct 2021
Typical duration for phase_3 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2027
ExpectedAugust 2, 2024
July 1, 2024
3.8 years
September 15, 2021
July 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between Adverse events (AEs) and gene profile
Correlation between Adverse events (AEs) and gene profile
Time from first subject dose to study completion, or up to 36 month
Secondary Outcomes (2)
Adverse events (AEs) rate according to CTCAE 5.0
Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and survival outcome
Time from first subject dose to study completion, or up to 36 month
Study Arms (3)
Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors
EXPERIMENTALLung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
Cohort B: Immune Checkpoint Inhibitors monotherapy
EXPERIMENTALLung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.
Cohort C: Chemotherapy Group.
EXPERIMENTALLung Cancer patients treated with Chemotherapy.
Interventions
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
Eligibility Criteria
You may qualify if:
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed lung cancer.
- Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
- \. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongchang Zhang, MD
Hunan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Clinical Trial Center
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 24, 2021
Study Start
October 1, 2021
Primary Completion
July 1, 2025
Study Completion (Estimated)
September 14, 2027
Last Updated
August 2, 2024
Record last verified: 2024-07