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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin 4-6 cycles every 3 weeks Drug: Cisplatin 4-6 cycles every 3 weeks Drug: Etoposide 4-6 cycles every 3 weeks
Research Site
Baoding, China
Percentage of Participants With Grade ≥3 AEs
Time frame: 19 months
Percentage of Participants With Immune-mediated Adverse Events (imAEs)
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.
Time frame: 19 months
Median Progression Free Survival (PFS)
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.
Time frame: 19 months
Proportion of Patients Alive and Progression Free at 12 Months (APF12)
The APF12 is defined as the Kaplan-Meier estimate of PFS (per investigator assessment according to RECIST v1.1 criteria) at 12 months.
Time frame: 12 months
Objective Response Rate (ORR)
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.
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Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Dalian, China
Research Site
Dongyang, China
Research Site
Guangdong, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Haerbin, China
Research Site
Hangzhou, China
...and 20 more locations
Time frame: 19 months
Median Overall Survival (OS)
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.
Time frame: 19 months
Proportion of Patients Alive at 12 Months (OS12)
The OS12 is defined as the Kaplan-Meier estimate of OS at 12 months
Time frame: 12 months
Duration of Response (DOR)
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.
Time frame: 19 months
Percentage of Participants With AEs
Time frame: 19 months
Percentage of Participants With SAEs
Time frame: 19 months
Percentage of Participants With Adverse Events of Special Interest (AESI)
Time frame: 19 months
Percentage of Participants With AEs Resulting in Treatment Discontinuation
Time frame: 19 months