DREAM study

Not Applicable

• Conditions: Small cell lung cancer

• Registration Number: JPRN-jRCTs051200109
• Lead Sponsor: Fujimoto Daichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Key inclusion criteria are as follows: 1) patients who have unresectable extensive disease, 2) patients whose tumor is histologically or cytologically confirmed small cell lung cancer, 3) patients aged >=20 years, 4) patients with Eastern Cooperative Oncology Group performance status of 0 to 1, 5) patients have no previous chemotherapy or immune checkpoint inhibitor for small cell lung cancer, 6) patients with chronic fibrotic IP, 7) patients diagnosed as Probable UIP pattern, Indeterminate for UIP pattern, and Alternative diagnosis pattern according to the ATS/ERS/JRS/LATS association official guidelines, and 8) patients with adequate organ function.

Exclusion Criteria

Key exclusion criteria are as follows: 1) any history of previous malignancy in the past 5 years, 2) any history of autoimmune disease (patients who have controlled thyroid dysfunction or skin disease that does not require systemic therapy eligible), 3) %VC <80%, 4) patients diagnosed as definite UIP pattern, 5) other interstitial lung disease including connective tissue disease-ILD, pneumoconiosis, and drug-induced pneumonitis, 6) history of taking corticosteroid, other immunosuppressive drug, pirfenidone, and nintedanib within 14 days before registration, and 7) patients with symptomatic brain metastasis or meningeal carcinomatosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified