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

Phase 3

Recruiting

• Conditions: Lung Cancer
• Interventions: Drug: Pemetrexed plus Pembrolizumab; Drug: Pemetrexed; Drug: Pembrolizumab

• Registration Number: NCT05055908
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Study Start: 2021-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-07-01
• Study Completion: 2027-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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.

5. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria

Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors	Pemetrexed plus Pembrolizumab	Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
Cohort C: Chemotherapy Group.	Pemetrexed	Lung Cancer patients treated with Chemotherapy.
Cohort B: Immune Checkpoint Inhibitors monotherapy	Pembrolizumab	Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.

Primary Outcome Measures

Name	Time	Method
Correlation between Adverse events (AEs) and gene profile	Time from first subject dose to study completion, or up to 36 month	Correlation between Adverse events (AEs) and gene profile

Secondary Outcome Measures

Name	Time	Method
Correlation between Adverse events (AEs) and survival outcome	Time from first subject dose to study completion, or up to 36 month	Correlation between Adverse events (AEs) and survival outcome
Adverse events (AEs) rate according to CTCAE 5.0	Time from first subject dose to study completion, or up to 36 month	Adverse events (AEs) rate according to CTCAE 5.0

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China