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

Lung Cancer Clinical Trial

— BECOME  

Official title:

Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055908
• Other study ID #: 20210913
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: September 14, 2027

Study information

• Verified date: June 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: September 14, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events (AEs) rate according to CTCAE 5.0	Adverse events (AEs) rate according to CTCAE 5.0	Time from first subject dose to study completion, or up to 36 month
Secondary	Correlation between Adverse events (AEs) and survival outcome	Correlation between Adverse events (AEs) and survival outcome	Time from first subject dose to study completion, or up to 36 month