Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.
The study will be conducted in North America, Europe and Turkey. In this single arm study participants will be treated with with durvalumab alone and concurrently with platinum-based chemotherapy and etoposide during the study period until radiological disease progression, unless there is clinical progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met, as per investigator assessment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Participants will receive durvalumab via IV infusion on Day 1 of each cycle.
Participants will receive cisplatin via IV administration on Day 1 of each cycle.
Participants will receive carboplatin via IV administration Day 1 of each cycle.
Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs)
Incidence of Grade 3 or higher adverse events to evaluate safety and tolerability profile of durvalumab + Platinum (cisplatin or carboplatin) plus etoposide (EP) treatment was assessed.
Time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs)
Immune mediated adverse events (imAEs) were assessed to evaluate safety and tolerability profile of durvalumab + EP treatment. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action (MOA) and where there is no clear alternate etiology.
Time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Progression-free Survival (PFS)
Efficacy of durvalumab + EP treatment by evaluating PFS according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was assessed. The PFS is the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from Investigational medicinal product (IMP) or received another anticancer therapy prior to progression.
Time frame: From first dose of study treatment until disease progression or death, up to 2.5 years.
Percentage of Participants Alive and Progression-free at 12 Months From First Date of Treatment (PFS12)
The efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1 was assessed.
Time frame: From first date of study treatment until 12 months.
Objective Response Rate (ORR)
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Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.
Research Site
Panagyurishte, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Montreal, Quebec, Canada
Research Site
Burgas, Czechia
Research Site
Olomouc, Czechia
Research Site
Ostrava, Czechia
Research Site
Berlin, Germany
...and 25 more locations
The efficacy of durvalumab + EP treatment by evaluating ORR according to RECIST 1.1 was assessed. The ORR will be assessed based on Investigator-assessed response to treatment of complete response (CR) and partial response (PR), per RECIST1.1.
Time frame: From screening until disease progression or the last evaluable assessment in the absence of progression, up to 2.5 years.
Duration of Response (DoR)
The efficacy of durvalumab + EP treatment by evaluating DoR according to RECIST 1.1 was assessed. The DoR is time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Percentage of Participants Remaining in Response, 12 Months After First Documented Objective Response (DoR12)
The efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1 was assessed.
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Overall Survival (OS)
Assessment of the efficacy of durvalumab + EP treatment by evaluating OS. The OS is the time from the first date of treatment until death due to any cause.
Time frame: From first dose of study treatment to death, up to 2.5 years.
Percentage of Participants Alive at 12 Months From First Date of Treatment (OS12)
The efficacy of durvalumab + EP treatment by evaluating OS12 was assessed.
Time frame: From first dose of study treatment till 12 months.
Number of Participants With Adverse Events and Serious Adverse Events
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events and serious adverse events were assessed.
Time frame: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.
Number of Participants With Adverse Events of Special Interests
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events of special interests were assessed. An AESI is an AE of scientific and medical interest specific to understanding of the IMP. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants, and/or hormone replacement therapy. This includes adverse events of special/ possible interest.
Time frame: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.