Status:
COMPLETED
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
Lead Sponsor:
Chugai Pharmaceutical
Collaborating Sponsors:
Japan Lung Cancer Society
Conditions:
Non-small Cell Lung Cancer
Extensive Disease Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Brief Summary
This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell l...
Detailed Description
Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (...
Eligibility Criteria
Inclusion
- \< non-small cell lung cancer cohort\>
- Patients 20 years of age or older at the time of signed consent.
- Patients with unresectable, advanced and recurrent non-small cell lung cancer.
- Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
- 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\>
- Patients 20 years of age or older at the time of signed consent.
- Patients with extensive disease small cell lung cancer.
- Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
- 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.
Exclusion
- \< 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.
Key Trial Info
Start Date :
August 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
1221 Patients enrolled
Trial Details
Trial ID
NCT04501497
Start Date
August 21 2020
End Date
February 3 2023
Last Update
April 2 2024
Active Locations (148)
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1
Akashi Medical Center
Akashi, Japan
2
Hyogo Cancer Center
Akashi, Japan
3
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Japan
4
Asahikawa Medical University Hospital
Asahikawa, Japan