Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Conditions

Non-small cell lung cancer

Brief summary

OS is defined as the time from the date of randomization until death due to any cause in the Intent-to-Treat (ITT) Analysis Set.

Detailed description

PFS is defined as the time from the date of randomization until the date of objective disease progression or death (whichever comes first) as assessed by the investigator per RECIST Version 1.1., ORR is defined as the proportion of patientsparticipants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by the investigator per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by the investigator per RECIST Version 1.1., DCR is defined as the proportion of patientsparticipants who achieve a CR, PR, or stable disease (SD) as assessed by the investigator per RECIST Version 1.1., Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities., Time to first deterioration in shortness of breath domain as measured by NSCLC-SAQ., Time to first deterioration in NSCLC-SAQ total score.

Related papers

No related papers found yet.

Interventions

DRUGDocetaxel Accord 20 mg/1 ml concentrate for solution for infusion

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS is defined as the time from the date of randomization until death due to any cause in the Intent-to-Treat (ITT) Analysis Set.	—

Secondary

Measure	Time frame
PFS is defined as the time from the date of randomization until the date of objective disease progression or death (whichever comes first) as assessed by the investigator per RECIST Version 1.1., ORR is defined as the proportion of patientsparticipants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by the investigator per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by the investigator per RECIST Version 1.1., DCR is defined as the proportion of patientsparticipants who achieve a CR, PR, or stable disease (SD) as assessed by the investigator per RECIST Version 1.1., Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities., Time to first deterioration in shortness of breath domain as measured by NSCLC-SAQ., Time to first deterioration	—

Measure

Time frame

PFS is defined as the time from the date of randomization until the date of objective disease progression or death (whichever comes first) as assessed by the investigator per RECIST Version 1.1., ORR is defined as the proportion of patientsparticipants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by the investigator per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by the investigator per RECIST Version 1.1., DCR is defined as the proportion of patientsparticipants who achieve a CR, PR, or stable disease (SD) as assessed by the investigator per RECIST Version 1.1., Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities., Time to first deterioration in shortness of breath domain as measured by NSCLC-SAQ., Time to first deterioration

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Countries

Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed