Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT

Primary outcomes

• Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0] [Within 6 months of starting Durvalumab]

Secondary outcomes

• Real world PFS (rwPFS) [From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months]
• ORR (Objective response rate from starting with Durvalumab treatment) [Up to 60 months]
• DoR (Duration of response from starting with Durvalumab treatment) [From the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, Up to 60 months]
• DCR (Disease control rate from staring with Durvalumab treatment) [Up to 60 months]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Aged ≥18 at initial diagnosis;
2. Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
3. Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
4. Start Durvalumab treatment within 3 months after sCRT;
5. Permitted PCI;
6. WHO PS 0-2 before sCRT.

Exclusion Criteria:

1. ES-SCLC or mixed SCLC and NSCLC histology;
2. Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
3. Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.