Durvalumab after sequential chemoradiotherapy for limited-stage small cell lung cancer

A Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)

We will try giving Durvalumab as a follow-up treatment to people with limited-stage small cell lung cancer who did not progress after sequential chemoradiotherapy.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: Durvalumab, chemotherapy
• Locations: 4 sites (Jinan and 3 other locations)
• Trial ID: NCT07309211 on ClinicalTrials.gov

What this trial studies

This is a retrospective, multi-center, single-arm study enrolling 25 patients who received Durvalumab as consolidation after completing sequential chemoradiotherapy (sCRT) for limited-stage SCLC. The primary outcome is the incidence of Grade 3–4 adverse events within six months of starting Durvalumab, graded by CTCAE v5.0. Secondary outcomes include real-world progression-free survival, objective response rate, duration of response, and disease control rate. Eligible patients started Durvalumab within three months of sCRT, had WHO performance status 0–2 before sCRT, and could have received prophylactic cranial irradiation per physician discretion.

Who should consider this trial

Good fit: Adults with limited-stage SCLC who completed sequential chemoradiotherapy without progression, started Durvalumab within three months, have WHO performance status 0–2, and do not have active autoimmune disease are ideal candidates.

Not a fit: Patients with extensive-stage disease, mixed SCLC/NSCLC histology, unresolved grade ≥2 toxicity from prior treatment, active autoimmune or uncontrolled intercurrent illness, or those who received concurrent chemoradiotherapy are unlikely to benefit from this consolidation approach.

Why it matters

Potential benefit: If successful, this could support using Durvalumab after sCRT to improve disease control and extend the time patients remain progression-free while describing its safety in this group.

How similar studies have performed: Immune checkpoint inhibitor consolidation has shown benefit in other lung cancer settings (for example PACIFIC in stage III NSCLC and ICIs in extensive-stage SCLC), but consolidation specifically after sequential chemoradiotherapy for limited-stage SCLC is less well studied.

Eligibility criteria

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.

Where this trial is running

Jinan and 3 other locations

• Cancer Hospital of Shandong First Medical University — Jinan, China (Recruiting)
• Nanjing Chest Hospital — Nanjing, China (Not_yet_recruiting)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, China (Recruiting)
• The affiliated hospital of qingdao university — Qingdao, China (Recruiting)

Study contacts

• Study coordinator: Xin Zhao

Conditions SCLC, Limited Stage