IFCT-2404 COMET A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients with Advanced MET exon 14 Mutated Non-Small Cell Lung Cancer

Conditions

Advanced MET exon 14 Mutated Non-Small Cell Lung Cancer

Brief summary

Progression-free survival (PFS) assessed by independent review committee according to RECIST 1.1.

Detailed description

Hierarchical analysis #1: Quality of life: change from baseline to week 6 in QLQ-C30 global health status/Quality of life (GHS/QOL) score, using the EORTC QLQ-C30 questionnaire with lung cancer module QLQ-LC29), tested if the primary endpoint (PFS) shows statistical significance., Hierarchical analysis #2: Overall survival, tested if the primary endpoint (PFS) and the first secondary endpoint (QoL) both show statistical significance., Objective Response Rate according to RECIST1.1., Duration of response., Second progression-free survival (PFS2) and Time to next treatment or death (TNT-D)., Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)., Number of cycles for each arm, Number of treatment dose modification and interruption.

Related papers

No related papers found yet.

Interventions

DRUGNIVOLUMAB

DRUGGEMCITABINE

DRUGTEPMETKO 225 mg film-coated tablets

DRUGPACLITAXEL

DRUGDOCETAXEL

DRUGATEZOLIZUMAB

DRUGBEVACIZUMAB

DRUGPEMBROLIZUMAB

DRUGVINORELBINE

DRUGPEMETREXED

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) assessed by independent review committee according to RECIST 1.1.	—

Secondary

Measure	Time frame
Hierarchical analysis #1: Quality of life: change from baseline to week 6 in QLQ-C30 global health status/Quality of life (GHS/QOL) score, using the EORTC QLQ-C30 questionnaire with lung cancer module QLQ-LC29), tested if the primary endpoint (PFS) shows statistical significance., Hierarchical analysis #2: Overall survival, tested if the primary endpoint (PFS) and the first secondary endpoint (QoL) both show statistical significance., Objective Response Rate according to RECIST1.1., Duration of response., Second progression-free survival (PFS2) and Time to next treatment or death (TNT-D)., Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)., Number of cycles for each arm, Number of treatment dose modification and interruption.	—

Measure

Time frame

Hierarchical analysis #1: Quality of life: change from baseline to week 6 in QLQ-C30 global health status/Quality of life (GHS/QOL) score, using the EORTC QLQ-C30 questionnaire with lung cancer module QLQ-LC29), tested if the primary endpoint (PFS) shows statistical significance., Hierarchical analysis #2: Overall survival, tested if the primary endpoint (PFS) and the first secondary endpoint (QoL) both show statistical significance., Objective Response Rate according to RECIST1.1., Duration of response., Second progression-free survival (PFS2) and Time to next treatment or death (TNT-D)., Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)., Number of cycles for each arm, Number of treatment dose modification and interruption.

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Countries

France

Outcome results

None listed