The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

Completed

• Conditions: Non-small Cell Lung Cancer; Extensive Disease Small Cell Lung Cancer

• Registration Number: NCT04818983
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Study Start: 2021-04-07
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.

<non-small cell lung cancer cohort>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

<extensive disease small cell lung cancer cohort>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with extensive disease small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.

Exclusion Criteria

<non-small cell lung cancer cohort>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.

<extensive disease small cell lung cancer cohort>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy	Baseline, Predose of cycle 2 (each cycle is 21 days), and when immune-related adverse event occurs (through study completion, an average of 2 years 5 months)
Correlation between PD-L1 SNP and atezolizumab combination therapy	Baseline
Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy	Baseline

Trial Locations

Locations (95)

Hyogo Cancer Center; 🇯🇵 Akashi, Japan

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa, Japan

National Hospital Organization Asahikawa Medical Center; 🇯🇵 Asahikawa, Japan

Juntendo University Hospital; 🇯🇵 Bunkyō-Ku, Japan

Nippon Medical School Hospital; 🇯🇵 Bunkyō-Ku, Japan

Tokyo Medical And Dental University, Medical Hospital; 🇯🇵 Bunkyō-Ku, Japan

Chiba University Hospital; 🇯🇵 Chiba, Japan

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

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