Clinical trial · Observational
Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
- 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 non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study. The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.
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 |
|---|---|---|---|
| Small Cell Lung Cancer (SCLC) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Durvalumab Group
- description
- Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.
- interventionNames
- Drug: Durvalumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months
- description
- To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
Secondary outcomes (3)
- measure
- 1-year survival rate
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8). 2. Age ≥ 18 years at time of study Entry 3. Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation 4. Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018. 5. Patients must have been treated with at least one dose of durvalumab within the EAP 6. Alive patients must have signed, dated and IRB/EC-approved written informed consent\* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Exclusion Criteria: 1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form. 2. Patients who were accepted in the EAP, but did not receive treatment. 3. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
References
Publications (0)
Data not yet available