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NCT Number: NCT05055908

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed lung cancer.
  • Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
  • 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.

Treatment and study plan

Pemetrexed plus Pembrolizumab

Drug

Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days

Other names: Bevacizumab

Pembrolizumab

Drug

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

Pemetrexed

Drug

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

Other names: Bevacizumab

Primary outcomes

  1. Correlation between Adverse events (AEs) and gene profile

    Time frame: Time from first subject dose to study completion, or up to 36 month

    Correlation between Adverse events (AEs) and gene profile

Secondary outcomes

  1. Adverse events (AEs) rate according to CTCAE 5.0

    Time frame: Time from first subject dose to study completion, or up to 36 month

    Adverse events (AEs) rate according to CTCAE 5.0

  2. Correlation between Adverse events (AEs) and survival outcome

    Time frame: Time from first subject dose to study completion, or up to 36 month

    Correlation between Adverse events (AEs) and survival outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Acronym: BECOME

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 24, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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