A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions

Non-Small Cell Lung Cancer

Brief summary

Part A: Incidence of DLTs., Part C: ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 (Safety endpoints: see below), Part D: ORR, defined as the proportion of subjects with a confirmed CR or PR, as assessed by BICR based on RECIST v1.1, Part A and Part B: Incidence of TEAEs, and SAEs overall, by severity, by relationship to THIO and/or cemiplimab, and those that led to discontinuation of THIO and cemiplimab and/or withdrawal from study, Part A and Part B: • ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 • DCR defined as the proportion of subjects with CR, PR, or SD, as assessed by the investigator based on RECIST v1.1

Detailed description

Part A and Part B: DoR, PFS, and OS, Part C: • DoR, DCR, PFS, as assessed by the Investigator based on RECIST v1.1 •OS, Part D: • DoR, DCR, PFS, as assessed by BICR based on RECIST v1.1 •ORR, DoR, DCR, PFS, as assessed by the Investigator based on RECIST v1.1 OS

Related papers

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Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGTHIO

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A: Incidence of DLTs., Part C: ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 (Safety endpoints: see below), Part D: ORR, defined as the proportion of subjects with a confirmed CR or PR, as assessed by BICR based on RECIST v1.1, Part A and Part B: Incidence of TEAEs, and SAEs overall, by severity, by relationship to THIO and/or cemiplimab, and those that led to discontinuation of THIO and cemiplimab and/or withdrawal from study, Part A and Part B: • ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 • DCR defined as the proportion of subjects with CR, PR, or SD, as assessed by the investigator based on RECIST v1.1	—

Measure

Time frame

Part A: Incidence of DLTs., Part C: ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 (Safety endpoints: see below), Part D: ORR, defined as the proportion of subjects with a confirmed CR or PR, as assessed by BICR based on RECIST v1.1, Part A and Part B: Incidence of TEAEs, and SAEs overall, by severity, by relationship to THIO and/or cemiplimab, and those that led to discontinuation of THIO and cemiplimab and/or withdrawal from study, Part A and Part B: • ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1 • DCR defined as the proportion of subjects with CR, PR, or SD, as assessed by the investigator based on RECIST v1.1

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Secondary

Measure	Time frame
Part A and Part B: DoR, PFS, and OS, Part C: • DoR, DCR, PFS, as assessed by the Investigator based on RECIST v1.1 •OS, Part D: • DoR, DCR, PFS, as assessed by BICR based on RECIST v1.1 •ORR, DoR, DCR, PFS, as assessed by the Investigator based on RECIST v1.1 OS	—

Countries

Bulgaria, Hungary, Poland, Romania

Outcome results

None listed