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Amivantamab and Lazertinib vs Osimertinib vs Lazertinib in First-Line EGFR-Mutated NSCLC
NCT04487080Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2020
- Primary completion
- Aug 2023
- Countries
- 28
- Sponsor
- Janssen Pharmaceutical
- Modality
- Fragment-Derived Small Molecules, Bispecific Antibodies, Orthosteric Ligands
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, double-blind trial in non-small cell lung cancer (NSCLC) comparing Amivantamab + Lazertinib, Osimertinib + Placebo and Lazertinib + Placebo (3 arms). Primary endpoint: Progression-Free Survival at 32.8 months. Started Sep 2020; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Amivantamab + Lazertinib
Amivantamab IV + Lazertinib oral (Open-label)
Osimertinib + Placebo
Osimertinib oral + Placebo Lazertinib oral (Double-blind)
Lazertinib + Placebo
Lazertinib oral + Placebo Osimertinib oral (Double-blind)
03
Who it enrols
Treatment-naive patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
Duration of Response
Progression-Free Survival After First Subsequent Therapy
Time to Symptomatic Progression
Intracranial Progression-Free Survival
Incidence and Severity of Adverse Events
Number of Participants With Clinical Laboratory Abnormalities
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