Clinical Trial: NCT04487080
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Official Title
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Amivantamab
- Drug: Osimertinib
- Drug: Lazertinib
- Drug: Placebo
Other Study ID Numbers
- CR108856
- 73841937NSC3003
- 2020-000743-31
- 2023-506576-27-00
- 2023
Start Date (Actual)
2020-09-30
Primary Completion Date (Actual)
2023-08-11
Study Completion Date (Estimated)
2028-02-16
Enrollment (Actual)
1074
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Official Title
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Amivantamab
- Drug: Osimertinib
- Drug: Lazertinib
- Drug: Placebo
Other Study ID Numbers
- CR108856
- 73841937NSC3003
- 2020-000743-31
- 2023-506576-27-00
- 2023
Start Date (Actual)
2020-09-30
Primary Completion Date (Actual)
2023-08-11
Study Completion Date (Estimated)
2028-02-16
Enrollment (Actual)
1074
Study Type
Interventional
Phase
Phase 3