A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase 1/2
Completed
NCT04075396
| Condition | Carcinoma, Non-Small-Cell Lung |
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| Phase | Phase 1/2 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Completed |
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| Enrollment | 29 participants |
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| Interventions | Lazertinib |
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| Start date | Oct 16, 2019 |
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| Completion date | Jan 8, 2021 |
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| Results posted | Feb 28, 2024 |
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Summary
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of Lazertinib when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
Part D: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From Day 1 up to 14 months · Participants
| Lazertinib 240 mg | 15 Participants |
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| Lazertinib 320 mg | 13 Participants |
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Part D: Number of Participants With Clinically Significant Abnormalities in Vital Signs
From Day 1 up to 14 months · Participants
| Lazertinib 240 mg | 0 Participants |
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| Lazertinib 320 mg | 0 Participants |
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Part D: Number of Participants With Clinically Significant Abnormalities in Physical Examination
From Day 1 up to 14 months · Participants
| Lazertinib 240 mg | 8 Participants |
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| Lazertinib 320 mg | 2 Participants |
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Open in BENITIONS
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