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

  • STATUS
    Recruiting
  • End date
    Aug 16, 2023
  • participants needed
    1200
  • sponsor
    Chugai Pharmaceutical
Updated on 2 July 2021
Investigator
J-TAIL-2 study exective office
Primary Contact
University Hospital, Kyoto Prefectural University of Medicine (0.9 mi away) Contact
+154 other location
atezolizumab
recurrent non-small cell lung cancer
lung carcinoma

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 lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

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 (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

Details
Condition Non-Small Cell Lung Cancer, Extensive Stage Small Cell Lung Cancer, nsclc, small cell lung cancer, extensive stage
Clinical Study IdentifierNCT04501497
SponsorChugai Pharmaceutical
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

< 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 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
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