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NCT Number: NCT07309211

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

This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR).

sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC.

The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.

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Key information

Conditions

SCLC, Limited Stage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital of Shandong First Medical University, Jinan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 at initial diagnosis;
  • Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
  • 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;
  • Start Durvalumab treatment within 3 months after sCRT;
  • Permitted PCI;
  • WHO PS 0-2 before sCRT.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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]

    Time frame: Within 6 months of starting Durvalumab

Secondary outcomes

  1. Real world PFS (rwPFS)

    Time frame: From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months

  2. ORR (Objective response rate from starting with Durvalumab treatment)

    Time frame: Up to 60 months

  3. DoR (Duration of response from starting with Durvalumab treatment)

    Time frame: 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

  4. DCR (Disease control rate from staring with Durvalumab treatment)

    Time frame: Up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Zhao

CONTACT

[email protected]

18066047640

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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