This is a phase III, randomized, open-label, multicenter, global study to determine the
efficacy and safety of combining durvalumab ± tremelimumab with platinum based
chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP
alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Additional locations may be listed on ClinicalTrials.gov for NCT03043872.
See trial information on ClinicalTrials.gov for a list of participating sites.
Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab +
EP treatment compared with EP and the efficacy of durvalumab + EP treatment compared with
EP in terms of OS.
All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the
planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive
treatment with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or
standard of care- EP (Arm 3). Arm 1 and Arm 2 patients receive the treatment until
confirmed disease progression while Arm 3 patients receive up to 6 cycles of EP and
prophylactic cranial irradiation if clinically indicated, at the Investigators'
discretion.Patients who have discontinued treatment due to toxicity or symptomatic
deterioration, clinical progression, or who have commenced subsequent anticancer therapy
will be followed up until confirmed disease progression and for survival.
Targeted population are adult patients (aged ≥18 years) with histologically or
cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th
edition) IV SCLC [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are
too extensive or have tumor/nodal volume that is too large to be encompassed in a
tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.
Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1
week from the date of randomization, at Week 12 ±1 week from the date of randomization,
and then every 8 weeks ±1 week until confirmed objective disease progression.
An independent data monitoring committee (IDMC) comprised of independent experts will be
convened to confirm the safety and tolerability of the proposed dose and schedule of
durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early
stages of enrolment.
Lead OrganizationAstraZeneca Pharmaceuticals LP
