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

NCT ID: NCT05055908

Last Updated: 2024-08-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2027-09-14

Brief Summary

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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.

Detailed Description

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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.

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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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors

Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.

Group Type EXPERIMENTAL

Pemetrexed plus Pembrolizumab

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.

Cohort C: Chemotherapy Group.

Lung Cancer patients treated with Chemotherapy.

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

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

Intervention Type DRUG

Pembrolizumab

Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.

Intervention Type DRUG

Pemetrexed

Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.

Intervention Type DRUG

Other Intervention Names

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Bevacizumab Bevacizumab

Eligibility Criteria

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Inclusion Criteria

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor, Director of Clinical Trial Center

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

+8613873123436 ext. 7+861383123436

Nong Yang, MD

Role: CONTACT

+8613873123436 ext. +8613873123436

Facility Contacts

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Yongchang Zhang, MD

Role: primary

+86 731 89762323

Other Identifiers

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20210913

Identifier Type: -

Identifier Source: org_study_id

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