A Phase II, Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Refractory Extensive-Stage Small-Cell Lung Cancer
- Sponsor
- AstraZeneca
- Study ID
- NCT02937818
- Phase
- PHASE2
- Status
- Completed
Conditions
- Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab and Tremelimumab — DRUGDurvalumab + tremelimumab via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy via IV infusion q4w, starting on Week 16 until PD, or for other discontinuation criteria.
- AZD1775 and carboplatin (CBPT) — DRUGAZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks.
- AZD6738 and olaparib — DRUGAZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks
Study Details
Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy.
Key Dates
- Start date
- Nov 28, 2016
- Status verified
- May 2024
- Primary completion
- Jun 22, 2020
- Completion
- Nov 27, 2023
Study Design
- Enrollment
- 72 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ARM A
- Experimental: ARM B
- Experimental: ARM C
Primary Outcome Measure
Number of Participants With Overall Response [ Time Frame: Until disease progression [PD] (Up to 3.5 Years) ]