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

Hunan Province Tumor Hospital

Status and phase: Enrolling; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Pemetrexed plus Pembrolizumab; Drug: Pemetrexed; Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05055908

20210913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,000 participants in 3 patient groups

Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors

Experimental group

Description:

Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.

Treatment:

Drug: Pemetrexed plus Pembrolizumab

Cohort B: Immune Checkpoint Inhibitors monotherapy

Experimental group

Description:

Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.

Treatment:

Drug: Pembrolizumab

Cohort C: Chemotherapy Group.

Experimental group

Description:

Lung Cancer patients treated with Chemotherapy.

Treatment:

Drug: Pemetrexed