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Completed

NCT Number: NCT03645330

A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akashi Medical Center, Akashi, Japan

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About this study

Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 20 years of age or older at the time of signed consent.
  • Patients with locally advanced or metastatic non-small cell lung cancer.
  • Patients who are scheduled to start Atezolizumab monotherapy, 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

  • Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

Treatment and study plan

Primary outcomes

  1. 18 months survival rate

    Time frame: Baseline up to 18 Months

    Percentage of participants alive 18 months after initiation of treatment

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: Up to death (up to 4 years)

    OS was defined as the time from the first day of study treatment to death due to any cause

  2. 12 months survival rate

    Time frame: Up to 12 months

    Percentage of participants alive 12 months after initiation of treatment

  3. 24 months survival rate

    Time frame: Up to 24 months

    Percentage of participants alive 24 months after initiation of treatment

  4. Progression-Free Survival(PFS)

    Time frame: Up to disease progression or death whichever occurs first (up to 4 years)

    PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)

  5. Time to treatment failure (TTF)

    Time frame: Up to 4 years

    TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death

  6. Objective Response Rate(ORR)

    Time frame: Up to disease progression or death whichever occurs first (up to 4 years)

    Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1

  7. Disease Control Rate(DCR)

    Time frame: Up to 4 years

    Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1

  8. Duration of Response(DOR)

    Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

    Duration of Response as Assessed by the Investigator According to RECIST v1.1

  9. Percentage of Participants with adverse events(Adverse Reactions)

    Time frame: Up to 4 years

    The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0

  10. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

    Time frame: Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)

    EQ-5D-5L consists of five standardized questions. Evaluate the quality of life by converting the result obtained into scores (range: 1.000 to - 0.025). Higher values give better results.

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Collaborators

  • Japan Lung Cancer Society

Registry information

Official study title

Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2018
Registry last updated
Jul 22, 2022

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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