Clinical trial · Observational
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
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
NCT04501497CI-TRIAL-00075606completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Disease Small Cell Lung Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- NSCLC cohort (N=800)
- description
- Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
- label
- ED-SCLC cohort (N=400)
- description
- Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
Primary outcomes (1)
- measure
- 12 months survival rate
- timeFrame
- Baseline up to 12 Months
- description
- Percentage of participants alive 12 months after initiation of treatment
Secondary outcomes (11)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: \< 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 Use Promotion 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 Use Promotion 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. 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.
References
Publications (3)
- DERIVEDShimizu J, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Goto Y, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Yoshimori K, Shibata K, Tsuda T, Seike M, Ota T, Samata K, Kobayashi Y, Tanaka M, Gemma A. Atezolizumab + Chemotherapy in Older Patients With Lung Cancer in Japan. Cancer Sci. 2026 Jul;117(7):1935-1947. doi: 10.1111/cas.70411. Epub 2026 May 14. PMID 42135591
- DERIVEDGoto Y, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Shimizu J, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Watanabe Y, Katakami N, Kisohara A, Yamaguchi M, Kuroki H, Sugimoto M, Ashimura H, Tanaka M, Gemma A. Plasma Protein Analysis for Biomarker Discovery in Lung Cancer Treated With Atezolizumab Combination Therapy in J-TAIL-2. Cancer Sci. 2026 Jul;117(7):1948-1960. doi: 10.1111/cas.70375. Epub 2026 Apr 21. PMID 42014371
- DERIVEDShirasawa M, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Goto Y, Shimizu J, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Yatabe Y, Yoshida T, Kashima J, Oki M, Ashimura H, Kobayashi Y, Tanaka M, Gemma A. Potential Immune Microenvironment Biomarkers in SCLC: J-TAIL-2 Observational Study. JTO Clin Res Rep. 2025 Oct 29;7(3):100926. doi: 10.1016/j.jtocrr.2025.100926. eCollection 2026 Mar. PMID 41783745