A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

Conditions

Locally advanced or metastatic Non-Small Cell Lung Cancer

Brief summary

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]

Detailed description

1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]

Related papers

No related papers found yet.

Interventions

DRUGPEGFILGRASTIM

DRUGRinatabart Sesutecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]	—

Secondary

Measure	Time frame
1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]	—

Measure

Time frame

1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]

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Outcome results

None listed