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

NCT07050472 | Completed

• 1 other identifier: 2025YJZ41
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Small-cell Lung Cancer

Keywords

limited stage small-cell lung cancer; CRT; immunotherapy

Outcome Measures

Primary Outcomes (1)

• rwPFS

  From the start of Durvalumab treatment to disease progression (tumor assessed by investigator) or death for any reason

  Up to 60 months

Secondary Outcomes (3)

• DoT

  Up to 60 months

• real-world progression free survival rate at 24 months(rwPFS24)

  24 months after first dose of durvalumab

• overall survival rate at 24 months (OS24)

  24 months after first dose of durvalumab

Other Outcomes (1)

• Adverse Events

  From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment

Study Arms (1)

LS-SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 \[IASLC Staging Manual in Thoracic Oncology 2016\]).

You may qualify if:

• Aged ≥18 at initial diagnosis.
• 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 \[IASLC Staging Manual in Thoracic Oncology 2016\]).
• 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.

You may not qualify if:

• Mixed SCLC and NSCLC histology.
• Participated in other interventional clinical trial for the treatment of any cancer during durvalumab therapy.

Sponsors & Collaborators

• Anhui Shi, MD: lead

Study Sites (1)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 3, 2025
• Study Start: August 11, 2025
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)