Durvalumab consolidation after chemoradiation for limited-stage small-cell lung cancer in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study in China that follows patients with limited‑stage small‑cell lung cancer (LS‑SCLC) who completed definitive chemoradiation and did not progress. Patients receiving durvalumab as consolidation—whether after concurrent or sequential chemoradiation—will be followed in real‑world practice to record effectiveness and safety outcomes. The study will compare outcomes across different local chemoradiation modalities and regimens and document patterns of subsequent therapy after progression. Data will be collected from participating sites in multiple Chinese cities to reflect routine clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to provide informed consent
* Age ≥18 years
* Histologically or cytologically documented LS-SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\], that can be safely treated with definitive radiation doses. Excludes 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)
* ECOG PS 0-2 (prior to the first dose of durvalumab after CRT)
* No disease progression following cCRT/sCRT (cCRT refers to chemotherapy and radiotherapy are administered with overlap; sCRT refers to chemotherapy and radiotherapy are delivered in a sequential manner with no overlap)
* Patients who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians are eligible (the time interval from the end of cCRT/sCRT to the first dose of durvalumab consolidation should be within 3 months)

  * Patients who started durvalumab consolidation ≤3 months before enrolment in the study will be allowed (irrespective of whether they continue to receive durvalumab at time of enrolment or already discontinued treatment)

Exclusion Criteria:

* Patients treated with CRT only without subsequent durvalumab consolidation
* Patients received durvalumab or any other anti-PD-1/anti-PD-L1 antibodies along with CRT
* Patients who previously were involved, or currently are, or plan to be involved in any other interventional anti-cancer clinical studies for LS-SCLC
* Prior exposure to immune-mediated therapy including, but not limited to, other anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
* Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Cangzhou, China Recruiting
• Research Site
  Dongguan, China Recruiting
• Research Site
  Fuzhou, China Recruiting
• Research Site
  Guangzhou, China Recruiting
• Research Site
  Huzhou, China Recruiting

Study contacts

• Principal investigator: JinMing Yu, Doctor — Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.