Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-17

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, multicentre, observational study aims to assess the effectiveness and safety of durvalumab as consolidation treatment for patients with LS-SCLC who have not progressed following CRT in real-world setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multi-centre Chart Review Study of Stage I-III Non-Small Cell Lung Cancer in China

NCT07316062

Non-Small-Cell Lung

NOT_YET_RECRUITING

Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer

NCT06992583

Advanced Lung Cancer

RECRUITING PHASE1

Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung Cancer

NCT06945523

Advanced Lung Cancer

RECRUITING PHASE1

A Non Interventional Pilot Study on Machine Learning for ILD Detection Based on the Patient Data From Digital Devices in Unresectable Stage III Non-Small Cell Lung Cancer Patients Receiving Durvalumab

NCT04884269

Carcinoma, Non-Small-Cell Lung

COMPLETED

Efficacy and Safety of Microwave Ablation Combined With Camrelizumab and Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer: a Multicenter, Open, Prospective Study

NCT05532527

Nsclc

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the effectiveness and safety profile of durvalumab consolidation following CRT in patients with LS-SCLC will be investigated in a real-world setting. Clinical outcomes will be explored across different CRT modalities and regimens according to local practice. Additionally, evidence will be generated on durvalumab consolidation following CRT regardless of concurrent or sequential setting. The subsequent treatment patterns of patients who experience disease progression during or after durvalumab consolidation will also be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Limited Stage Small-Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LS-SCLC

Patients with LS-SCLC who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first line treatment at the discretion of physicians.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No