Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab in pre-treated patients with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A treatment cycles consists of 3 weeks (i.e. 21 days). Lurbinectedin will be administered by intravenous infusion on Day 1 every 3 weeks. Durvalumab will be administered by intravenous infusion on Day 1 every 3 weeks.
Treatment will be administered on a 21-days cycle basis up to a maximum of 6 cycles. Carboplatin will be administered by intravenous infusion on Day 1 every 3 weeks. Etoposide will be administered by intravenous infusion on Day 1-3 every 3 weeks
Institut Bergonié
Bordeaux, France
Assessment of the antitumor activity of lurbinectedin combined with durvalumab
Antitumor activity will be assessed in terms of of 6-month progression-free rate (rate of complete or partial responses or stable disease more than 24 weeks, as per RECIST v1.1 criteria) after blinded centralized radiological review
Time frame: 6 months
6-months objective response for experimental Arm
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Time frame: 6 months
Best overall response for experimental Arm
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for experimental Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Time frame: 1 year
2-year progression-free survival for experimental Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Time frame: 2 years
1-year overall survival for experimental Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
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Time frame: 1 year
2-years overall survival for experimental Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Time frame: 2 years
Safety profile for experimental Arm: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile for standard Arm: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Time frame: Throughout the treatment period, an expected average of 6 months
Assessment of the antitumor activity of carboplatin combined with etoposide
Antitumor activity will be assessed in terms of of 6-month progression-free rate (rate of complete or partial responses or stable disease more than 24 weeks, as per RECIST v1.1 criteria) after blinded centralized radiological review
Time frame: 6 months
6-months objective response for standard Arm
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Time frame: 6 months
Best overall response for standard Arm
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for standard Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Time frame: 1 year
2-year progression-free survival for standard Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Time frame: 2 years
1-year overall survival for standard Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Time frame: 1 year
2-years overall survival for standard Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Time frame: 2 years
Tumor immune cells levels
Levels of immune cells in tumor will be measured by immunohistochemistry
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood cytokines levels
Levels of cytokines in blood will be measured by ELISA
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood lymphocytes levels
Levels of lymphocytes in blood will be measured by flow cytometry
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood kynurenine levels
Levels of kynurenine in blood will be measured by ELISA
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)