A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab

Conditions

Small-Cell Lung Cancer (SCLC)

Brief summary

1. IRF-assessed progression-free survival (PFS) after randomization, defined as the time from randomization to the date of first occurrence of documented disease progression (as assessed by the IRF according to RECIST v1.1), or death from any cause (whichever occurs first), 2. Overall Survival after randomization, defined as the time from randomization to the date of death from any cause

Detailed description

1. Investigator-assessed progression-free survival (PFS), 2. Confirmed objective response rate (ORR) as determined by the IRF and investigator according to RECIST v1.1, 3. Duration of response (DOR) as determined by the IRF and investigator according to RECIST v1.1, 4. PFS rates at 6 months and 12 months as determined by the IRF and investigator according to RECIST v1.1, 5. OS rates at 12 months and 24 months, 6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, 7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group, 8. Time to confirmed deterioration (TTCD) from randomization in patient reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Related papers

No related papers found yet.

Interventions

DRUGLURBINECTEDIN

DRUGRO7508182

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. IRF-assessed progression-free survival (PFS) after randomization, defined as the time from randomization to the date of first occurrence of documented disease progression (as assessed by the IRF according to RECIST v1.1), or death from any cause (whichever occurs first), 2. Overall Survival after randomization, defined as the time from randomization to the date of death from any cause	—

Secondary

Measure	Time frame
1. Investigator-assessed progression-free survival (PFS), 2. Confirmed objective response rate (ORR) as determined by the IRF and investigator according to RECIST v1.1, 3. Duration of response (DOR) as determined by the IRF and investigator according to RECIST v1.1, 4. PFS rates at 6 months and 12 months as determined by the IRF and investigator according to RECIST v1.1, 5. OS rates at 12 months and 24 months, 6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, 7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group, 8. Time to confirmed deterioration (TTCD) from randomization in patient reported physical functioning and global health status as measured	—

Measure

Time frame

1. Investigator-assessed progression-free survival (PFS), 2. Confirmed objective response rate (ORR) as determined by the IRF and investigator according to RECIST v1.1, 3. Duration of response (DOR) as determined by the IRF and investigator according to RECIST v1.1, 4. PFS rates at 6 months and 12 months as determined by the IRF and investigator according to RECIST v1.1, 5. OS rates at 12 months and 24 months, 6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, 7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group, 8. Time to confirmed deterioration (TTCD) from randomization in patient reported physical functioning and global health status as measured

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Countries

Belgium, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed