Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer

NCT05761977 | Unknown

• 1 other identifier: HE1R/21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Small-cell Lung Cancer; Extensive-stage Small-cell Lung Cancer

Keywords

observational study; small- cell lung cancer; extensive-stage small-cell lung cancer; first line treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Progression free survival (PFS)

  in 6, 12 and up to 24 months

• Overall response rate (ORR)

  in 6 and up to 12 months

• 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

Study Arms (1)

Patient with extensive small-cell lung cancer

extensive small-cell lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Small- Cell Lung Cancer candidates for 1st- line immunotherapy plus platinum based chemotherapy (cisplatin or carboplatin plus etoposide) currently with active disease.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Metropolitan Hospital

Neo Faliro, 18547, Greece

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helena Linardou, MD

  Metropolitan Hospital of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Linardou, MD

CONTACT

+302104809339; elinardou@otenet.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 9, 2023
• Study Start: March 31, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)