DREAM study

JRCT ID: jRCTs051200109

Registered date:15/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Small cell lung cancer
• Date of first enrollment: 18/01/2021
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Patients will receive etoposide (<75 years old: 100mg/m2; >=75 years old: 80mg/m2; intravenously on day 1-3), carboplatin (area under the curve 5 mg/mL intravenously on day 1), and durvalumab (1500mg/body intravenously on day1) every three weeks for four cycles. Thereafter, patients will continue to receive durvalumab monotherapy (1500mg/body intravenously on day 1 every three weeks), until relapse, or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Severe_pneumonitis-free rate
• Secondary Outcome: progression-free survival, overall survival, time to treatment failure, time to pneumonitis, and rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.
• Exclude 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.

Related Information

• Primary Sponsor: Fujimoto Daichi
• Source(s) of Monetary Support: Astra Zeneca K.K.