Clinical trial · Observational
Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer
Durvalumab in Combination With Standard Chemotherapy for 1st Line Therapy of Patients With Extensive Stage Small Cell Lung Cancer: A Non-interventional, Prospective Observational Study of Clinical Practice, Quality of Life and Use of Health Resources in Real-world Clinical Practice (DRIVE)
- 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, multicenter, prospective observational study and registry of standard clinical practice in patients with Extensive Stage-Small Cell Lung Cancer (ES-SCLC) receiving 1st line treatment with Durvalumab in combination with standard chemotherapy (cisplatin or carboplatin + etoposide) in the approved indication, which will be carried out in Greece. In this study data will be collected prospectively based on real-world clinical practice. A prospective cohort of atients from centers of the Hellenic Cooperative Oncology Group (HeCOG) will be included. The study will be conducted in hospitals and by physicians specialized in lung cancer from different geographical areas of Greece.
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-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patient with extensive small-cell lung cancer
- description
- extensive small-cell lung cancer
Primary outcomes (1)
- measure
- Overall survival rates (OS)
- timeFrame
- up to 24 months
- description
- The primary objective of the study is to estimate the overall survival rates (OS) at 6,12 and 24 months for patients with extensive small-cell lung cancer treated with Durvalumab in combination with standard 1st-line chemotherapy with platinum-etoposide(cisplatin or carboplatin).
Secondary outcomes (11)
- measure
- Progression free survival (PFS)
- timeFrame
- in 6, 12 and up to 24 months
- description
- Evaluation of PFS from investigator
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients, regardless of race (residents in Greece), no younger than 18 years old at the initiation of treatment. * Patients with histologically or cytologically confirmed diagnosis of extensive Small Cell Lung Cancer (SCLC) * Patients who have not received prior systemic treatment for SCLC (chemotherapy or immunotherapy) * Patients for whom the decision to administer treatment with Durvalumab+chemotherapy has already been taken before their inclusion in the study and is clearly separated from the decision of the physician for the patient's participation in the current study. * Patients who have provided informed signed consent to participate in the study and to collect and analyze medical data related to the objectives of this study. Exclusion Criteria: * Patients with current diagnosis of primary cancer other than SCLC who require systemic or other treatment. * Patients who have previously received chemotherapy or immunotherapy for SCLC * Patients who are currently receiving or are expected to receive treatment with an investigational drug/medical device/intervention or who have received an investigational medicinal product within 1 month or 5 years half-life of the research agent (whichever is longer) before their initiation in this study.
References
Publications (0)
Data not yet available