A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
Disqualifiers
Clinically confirmed leptomeningeal carcinomatosis.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Significant cardiovascular disease within 3 months prior to enrollment
History of another primary malignancy
Trial design
Design model
Single group
Treatments tested in this trial
Lurbinectedin
DrugAdministered by intravenous (IV) infusion
Durvalumab
DrugAdministered by intravenous (IV) infusion
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Durvalumab and lurbinectedin treatment armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Investigator assessed PFS rate
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
Time frame
6 monthsSecondary outcomes
1
Investigator assessed PFS
PFS is defined as the time from the start of maintenance treatment until the first documentation of disease progression (as determined by the investigator according to RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame
Up to 2 years2
Investigator-assessed confirmed ORR
Confirmed Objective Response Rate (ORR) is the proportion of participants with Complete Response (CR) or Partial Response (PR) on 2 consecutive occasions ≥ 4 weeks apart, after the start of maintenance treatment, as determined by the investigator according to RECIST v1.1.
Time frame
Up to 2 years3
Number of participants requiring dose modification
Time frame
Up to 2 years4
Number of participants requiring discontinuations of any component of the combination therapy
Time frame
Up to 2 yearsSponsors and contacts
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Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
Source ClinicalTrials.gov