Clinical trial · Observational
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
NCT03995875CI-TRIAL-00083380AYAMEcompletedClinicalTrials.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 observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence of pneumonitis and AESI
- timeFrame
- 3 years
- description
- Pneumonitis and AESIs will be summarized at least following categories * Pneumonitis within three years from the start of durvalmab treatment * Pneumonitis and AESIs during treatment period of durvalmab * Pneumonitis and AESIs after durvalmab treatment
- measure
- To assess progression free survival (PFS) of durvalumab
- timeFrame
- PFS is assessed as PFS median for time of 3 years
- description
- PFS is defined as the time from the start of durvalumab treatment to first progression disease (PD) or death, whichever is earlier. In case the patients without progression or death, patients will be censored at the last follow-up date or the first date of the 1st subsequent treatment, whichever is earlier.
Secondary outcomes (2)
- measure
- To assess overall survaival (OS) of durvalumab
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy. * Patients who provided written informed consent. Exclusion Criteria: * Patients who would join Post Marketing Surveyllance for durvalumab. * Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment * Age \< 20
References
Publications (2)
- DERIVEDYamamoto N, Kenmotsu H, Ninomiya K, Akdemir B, Uematsu S, Fukui A, Koto R, Fujiwara M, Iwao C, Kitagawa H, Yoshino I, Gemma A, Mitsudomi T, Saito Y. Interstitial Lung Disease in Patients With Unresectable Stage III NSCLC Treated With Chemoradiotherapy Followed by Durvalumab in Japan: Analysis From the Multicenter Prospective AYAME Study. Thorac Cancer. 2026 May;17(10):e70299. doi: 10.1111/1759-7714.70299. PMID 42152809
- DERIVEDKenmotsu H, Saito Y, Ninomiya K, Uematsu S, Akdemir B, Fukui A, Koto R, Fujiwara M, Iwao C, Kitagawa H, Yoshino I, Gemma A, Mitsudomi T, Yamamoto N. Long-Term Safety and Effectiveness of Durvalumab in Unresectable Stage III NSCLC in Japan: A Multicenter Prospective Study (AYAME). J Thorac Oncol. 2026 Jan;21(1):160-173. doi: 10.1016/j.jtho.2025.08.010. Epub 2025 Aug 18. PMID 40835220