Trials / Active Not Recruiting
Active Not RecruitingNCT04487080
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,074 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amivantamab | Participants will receive amivantamab intravenously. |
| DRUG | Osimertinib | Participants will receive osimertinib capsules orally. |
| DRUG | Lazertinib | Participants will receive lazertinib tablets orally. |
| DRUG | Placebo | Participants will receive matching placebo orally. |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2023-08-11
- Completion
- 2027-06-29
- First posted
- 2020-07-27
- Last updated
- 2026-02-04
- Results posted
- 2024-10-09
Locations
267 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04487080. Inclusion in this directory is not an endorsement.