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

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 — DRUG
  Durvalumab + 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) — DRUG
  AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks.
• AZD6738 and olaparib — DRUG
  AZD6738 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

First listed

Oct 19, 2016

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) ]