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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| rwPFS | From date of first dose of durvalumab consolidation treatment until progression as assessed in real-world, or death due to any cause. The primary measure of interest is the median rwPFS. | From 3 months before enrolment to follow-up of up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| TTD | From date of first dose of durvalumab consolidation treatment until discontinuation of treatment for any reason, including disease progression, toxicity and death. The measure of interest is the median TTD. | From 3 months before enrolment to follow-up of up to 36 months |
| OS |
| Measure | Description | Time Frame |
|---|---|---|
| TRAE, SAE, irAE, other AEs | Treatment-related adverse event (TRAE), serious adverse event (SAE), immune-related adverse events (irAE), adverse events (AEs) leading to durvalumab dose interruption, discontinuation and AEs leading to death. | From 3 months before enrolment to follow-up of up to 36 months |
| TFST |
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)
Exclusion Criteria:
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Adult male or female patients (with age ≥18 years old) who able to provide informed consent received platinum-based cCRT/sCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians and no disease progression following cCRT/sCRT
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| JinMing Yu, Doctor | Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Beijing | China | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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From first dose of durvalumab consolidation treatment until the date of death due to any cause. 6, 12, 18, and 24-months landmark rate of OS will be described. |
| From 3 months before enrolment to follow-up of up to 36 months |
From date of first dose of durvalumab consolidation treatment until the start date of the first subsequent anti-cancer therapy after discontinuation of durvalumab, or death due to any cause. Median TFST will be described. |
| From 3 months before enrolment to follow-up of up to 36 months |
| Patterns of progression and post-progression therapy. | Number and percentage of subjects with certain progression sites will be described. | From 2 months before enrolment to follow-up of up to 35 months |
| rwPFS in subgroups | rwPFS will be analysed within pre-specified subgroups. | From 3 months before enrolment to follow-up of up to 36 months |
| Baseline characteristics | To describe baseline characteristics of patients who received prior cCRT and sCRT including the time from diagnosis to starting durvalumab and the time from the end of radiation to starting durvalumab. | During enrolment period up to 12 months |
| Recruiting |
| Cangzhou |
| China |
| Research Site | Recruiting | Dongguan | China |
| Research Site | Recruiting | Fuzhou | China |
| Research Site | Recruiting | Guangzhou | China |
| Research Site | Recruiting | Huzhou | China |
| Research Site | Recruiting | Jinan | 250117 | China |
| Research Site | Recruiting | Jinan | China |
| Research Site | Recruiting | Nanjing | China |
| Research Site | Recruiting | Nanning | China |
| Research Site | Recruiting | Ningbo | China |
| Research Site | Recruiting | Shanghai | China |
| Research Site | Recruiting | Shenyang | China |
| Research Site | Recruiting | Shijiazhuang | China |
| Research Site | Recruiting | Taiyuan | China |
| Research Site | Recruiting | Tianjing | China |
| Research Site | Terminated | Tianjing | China |
| Research Site | Recruiting | Wuhan | China |
| Research Site | Recruiting | Wuxi | China |
| Research Site | Recruiting | Yangzhou | China |
| Research Site | Recruiting | Zhengzhou | China |