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NCT Number: NCT04501497

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Extensive Disease Small Cell Lung Cancer 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: 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)

Who can participate

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

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.

Treatment and study plan

Primary outcomes

  1. 12 months survival rate

    Time frame: Baseline up to 12 Months

    Percentage of participants alive 12 months after initiation of treatment

Secondary outcomes

  1. Overall Survival

    Time frame: Up to death (up to 3 years)

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

  2. 6 moths survival rate

    Time frame: Up to 6 months

    Percentage of participants alive 6 months after initiation of treatment

  3. 18 moths survival rate

    Time frame: Up to 18 months

    Percentage of participants alive 18 months after initiation of treatment

  4. Progression-Free Survival(PFS)

    Time frame: Up to disease progression or death whichever occurs first (up to 3 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 3 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. Post-treatment transfer rate

    Time frame: Up to post-treatment is started (up to 3 years)

    Rate of patients who received drug therapy for primary disease after study treatment

  7. Objective Response Rate(ORR)

    Time frame: Up to disease progression or death whichever occurs first (up to 3 years)

    Percentage of participants with objective response 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 3 years)

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

  9. Disease Control Rate(DCR)

    Time frame: Up to 3 years

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

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

    Time frame: Up to 3 years

    The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0

  11. Comprehensive geriatric assessment (G8)

    Time frame: At baseline

    The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Collaborators

  • Japan Lung Cancer Society

Registry information

Official study title

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2020
Registry last updated
Apr 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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