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A Phase II Study of Chemo-Immunotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738) in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Big Ten Cancer Research Consortium BTCRC-LUN18-363
The primary objective of this single arm study is to estimate the progression free survival of previously-untreated patients with extensive stage small cell lung cancer. Patients will receive initial chemo-immunotherapy followed by maintenance therapy with durvalumab and oral ceralasertib.
Details
| Lead sponsor | Muhammad Furqan |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2021-04-20 |
| Completion | 2026-11 |
Conditions
- Extensive Stage Small Cell Lung Cancer
Interventions
- Cisplatin
- Carboplatin
- Etoposide
- Durvalumab
- Ceralasertib
Primary outcomes
- Progression Free Survival (PFS) — From enrollment until the time of disease progression, assessed for a maximum of 24 months
Progression free survival (PFS) is defined as the time from the initiation of treatment (C1D1) to the time when the criteria for disease progression is met as defined by RECIST v1.1 OR death due to any cause. The PFS is subject to right censoring due to loss to follow-up or at the end of study duration.
Countries
United States