Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
ConditionLimited Stage Small-Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: LS-SCLC
Trial outcomes
Primary outcomes
1
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.
Time frame
From 3 months before enrolment to follow-up of up to 36 monthsSecondary outcomes
1
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.
Time frame
From 3 months before enrolment to follow-up of up to 36 months2
OS
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.
Time frame
From 3 months before enrolment to follow-up of up to 36 monthsOther outcomes
1
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.
Time frame
From 3 months before enrolment to follow-up of up to 36 months2
TFST
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.
Time frame
From 3 months before enrolment to follow-up of up to 36 months3
Patterns of progression and post-progression therapy.
Number and percentage of subjects with certain progression sites will be described.
Time frame
From 2 months before enrolment to follow-up of up to 35 months4
rwPFS in subgroups
rwPFS will be analysed within pre-specified subgroups.
Time frame
From 3 months before enrolment to follow-up of up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov