Study of AZD2811 + Durvalumab in ES-SCLC

Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in

patients who have not progressed following induction therapy with platinum-based

chemotherapy combined with durvalumab.

This is an open-label, single arm study. Patients will be treated in an induction phase

with platinum-based induction therapy and durvalumab. At the end of this induction

period, participants will be assessed for disease progression, per RECIST v1.1.

Participants who have not progressed per RECIST v1.1 at the end of the induction phase

will roll over into the maintenance phase of the trial, where patients will commence

AZD2811 and durvalumab combination.

Participants will be treated with AZD2811 and durvalumab as maintenance therapy until

confirmed progressive disease, start of non-protocol defined anticancer therapy,

unacceptable toxicity, or withdrawal of consent.

If study intervention is permanently discontinued, the participant will remain in the

study to be evaluated for safety assessment, as well as for 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 every 6 weeks

± 1 week for the first 36 weeks, and then every 8 weeks ±1 week until confirmed objective

disease progression.