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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Pemetrexed plus Pembrolizumab; Drug: Pembrolizumab; Drug: Pemetrexed

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 Type: Interventional
• Enrollment (Estimated): 12000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yongchang Zhang, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Nong Yang, MD; Phone Number: +8613873123436 +8613873123436; Email: yangnong0217@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762323; Email: zhangyongchang@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors; Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.	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; Other Names: Bevacizumab
Experimental: Cohort B: Immune Checkpoint Inhibitors monotherapy; Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.	Drug: Pembrolizumab; Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
Experimental: Cohort C: Chemotherapy Group.; Lung Cancer patients treated with Chemotherapy.	Drug: Pemetrexed; Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.; Other Names: Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Investigators: Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): September 14, 2027

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Bevacizumab; Pembrolizumab; Pemetrexed
• Other Study ID Numbers: 20210913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No