Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
In this observational prospective study, no changes to current therapeutic practice will be required and all aspects of treatment and clinical management of patients will be in compliance with the local clinical practice and will be left to the discretion of the participating physicians. Patients will be treated in accordance with the study medicine's local prescribing information and standard clinical practice as to the frequency of visits and types of evaluations carried out. The frequency of follow-up visits is set on the basis of standard practice; however, the study-related data will be collected during integration and during the routine clinical visits that will take place after the start of treatment. No visits or measurement/evaluation will be mandatory by the protocol and data collection at the predetermined time-points will be carried out only if the patient visits the center.
Patients will be enrolled during a 12-month recruitment period from HeCOG-participating public and private centers/clinics in Greece with specialization in lung cancer. As part of this study, participating physicians will be asked to follow up each patient for an additional 12 months of treatment at most after last subject is included, or until death, withdrawal of consent, discontinuation of treatment or initiation of new antineoplastic therapy, until completion of the study, or doctor's decision, whichever appears first. Therefore, the maximum period of prospective observation of the study will be 24 months (2 years) from the last patient enrolled in the study. This study will be conducted in accordance with the Guidelines for Good Pharmacoepidemiological Practice, the European General Data Protection Regulation (GDPR) and the applicable regulatory requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with extensive small-cell lung cancer | extensive small-cell lung cancer |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rates (OS) | 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). | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Evaluation of PFS from investigator | in 6, 12 and up to 24 months |
| Overall response rate (ORR) | in 6 and up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with Small- Cell Lung Cancer candidates for 1st- line immunotherapy plus platinum based chemotherapy (cisplatin or carboplatin plus etoposide) currently with active disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Linardou, MD | Contact | +302104809339 | elinardou@otenet.gr |
| Name | Affiliation | Role |
|---|---|---|
| Helena Linardou, MD | Metropolitan Hospital of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Hospital | Recruiting | Neo Faliro | 18547 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Disease Control Rate | in 6 and up to 12 months |
| time to reach a response (TTR) | up to 12 months |
| duration of the response (DoR) | up to 12 months |
| Assessment of patients characteristics with overall survival 12 months | up to 12 months |
| Assessment of patients characteristics with overall survival 24 months | up to 24 months |
| time under treatment (ToT) | up tp 24 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 with standard of care 1st line treatment | From date of Informed Consent signatory and every 3 weeks, up to 24 months |
| Quality of life EQ-5D | From date of Informed Consent signatory and every 2 months, up to 24 months |
| number of participants using health resources in daily clinical practice | From date of Informed Consent signatory and every 3 weeks, up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |