Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors
NCT ID: NCT05055908
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
12000 participants
INTERVENTIONAL
2021-10-01
2027-09-14
Brief Summary
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Detailed Description
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Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.
Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors
Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
Pemetrexed plus Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
Cohort B: Immune Checkpoint Inhibitors monotherapy
Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.
Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
Cohort C: Chemotherapy Group.
Lung Cancer patients treated with Chemotherapy.
Pemetrexed
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
Interventions
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Pemetrexed plus Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
Pemetrexed
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed lung cancer.
4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
6\. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
18 Years
ALL
No
Sponsors
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Hunan Province Tumor Hospital
OTHER
Responsible Party
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Yongchang Zhang
Professor, Director of Clinical Trial Center
Principal Investigators
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Yongchang Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20210913
Identifier Type: -
Identifier Source: org_study_id
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