Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)
- Conditions
- Small Cell Lung Carcinoma Extensive Disease
- Interventions
- Registration Number
- NCT04449861
- Lead Sponsor
- AstraZeneca
- Brief Summary
This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Durvalumab plus 4-6 cycles chemotherapy Durvalumab plus chemotherapy Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Grade ≥3 AEs 19 months Percentage of Participants With Immune-mediated Adverse Events (imAEs) 19 months An immune-mediated adverse event (imAE) is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate aetiology.
- Secondary Outcome Measures
Name Time Method Median Progression Free Survival (PFS) 19 months PFS by investigator assessment according to RECIST v1.1 criteria
Progression-free survival is defined as the time from first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from study therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment of investigator. However, if the patient progresses or dies after 2 or more missed visits, the patient will be censored at the time of the latest assessment. If the patient has no evaluable visits or does not have baseline data, they will be censored at the day of first dose unless they die within 2 visits of baseline.Proportion of Patients Alive and Progression Free at 12 Months (APF12) 12 months The APF12 is defined as the Kaplan-Meier estimate of PFS (per investigator assessment according to RECIST v1.1 criteria) at 12 months.
Objective Response Rate (ORR) 19 months Objective Response Rate is defined as the number (%) of patients with measurable disease with at least 1 visit response of CR or PR. Data obtained up until progression or last evaluable assessment in the absence of progression will be included in the assessment of ORR. Any CR or PR which occurred after a further anti-cancer therapy was received will not be included in the numerator for the ORR calculation.
Median Overall Survival (OS) 19 months Overall survival is defined as the time from the date of first dose of study treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Proportion of Patients Alive at 12 Months (OS12) 12 months The OS12 is defined as the Kaplan-Meier estimate of OS at 12 months
Duration of Response (DOR) 19 months Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.
Percentage of Participants With AEs 19 months Percentage of Participants With SAEs 19 months Percentage of Participants With Adverse Events of Special Interest (AESI) 19 months Percentage of Participants With AEs Resulting in Treatment Discontinuation 19 months
Trial Locations
- Locations (1)
Research Site
🇨🇳Zhengzhou, China