Durvalumab After Concurrent Chemoradiotherapy (cCRT) for Limited-stage Small-cell Lung Cancer (LS-SCLC)

NCT ID: NCT07050472

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-08-31

Brief Summary

This is a retrospective, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting.

Detailed Description

Eligible LS-SCLC patients who received cCRT, and subsequent durvalumab from January 1st, 2020 till December 31st, 2023 will be identified and included for retrospective data collection and analyses in this study. Approximately 35~45 patients are planned to be enrolled. The first date of the presence of durvalumab treatment will be considered the index date for patients. Data is planned to be collected from date of histologically diagnosis up to December 31, 2024. The primary endpoint real-world PFS is defined as the time from the index date to disease progression (determined based on either radiological or clinical evidence) or death for any reason. Duration of durvalumab treatment and 2 year (relative to the first dose of durvalumab) rwPFS rate and OS rate will be measured.

Study data will come from what have been generated from routine clinical practice in the study hospital, e.g., the diagnosis, treatment and tumor assessments (CT or MRI, usually every 3 months for years 1~2, and every 6 months for years 3~5) information. Data collection, cleaning, and query will follow the traditional clinical study execution process. Investigators at study site will be responsible to ensure that data is accurate, clear, and traceable.

Conditions

Small-cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

LS-SCLC

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 at initial diagnosis.

2. Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).

3. Received concurrent chemoradiotherapy (cCRT) as first-line treatment and consolidative durvalumab prior to disease progression or death:

• Received 4 cycles of platinum-based chemotherapy concurrent with radiotherapy.
• The chemotherapy regimen must contain carboplatin/cisplatin and etoposide.
• Received a total dose of radiation of 60 to 66 Gy over 6 weeks for standard QD radiation schedules, 45 Gy over 3 weeks or a simultaneous integrated boost of 54 Gy over 3 weeks for hyperfractionated BID radiation schedules.
• Radiotherapy must have commenced no later than the end of Cycle 2 of chemotherapy.
• Received at least 1 dose of durvalumab. The first dose of durvalumab received between 1 Jan 2020 and 31 Dec 2023 at Peking University Cancer Hospital.

Exclusion Criteria

1. Mixed SCLC and NSCLC histology.

2. Participated in other interventional clinical trial for the treatment of any cancer during durvalumab therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Shi, MD

OTHER

Sponsor Role: lead

Responsible Party

Anhui Shi, MD

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Anhui Shi, MD

Role: CONTACT

anhuidoctor@163.com

139 0113 6511

JiaYi Yu, MD

Role: CONTACT

yujiayi0323@foxmail.com

18518362213

Facility Contacts

AnHui Shi, MD

Role: primary

anhuidoctor@163.com

139 0113 6511

Other Identifiers

2025YJZ41

Identifier Type: -

Identifier Source: org_study_id