CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,074 enrolled / 1,074 target
Drug / intervention
Amivantamab +3 moredrug
Likely dose
1050 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04487080
NCT04487080Phase 3ActiveUpdate Overdue (15.6/mo)Completion was 34mo ago
CompareCT.gov

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.

Janssen Research & Development, LLC·interventional·Posted Jul 27, 2020·Updated Jun 8, 2026

In Brief

A Phase 3 clinical trial evaluating Amivantamab, Osimertinib, and 2 other interventions for Carcinoma, Non-Small-Cell Lung. Active but no longer recruiting, targeting 1,074 participants across 269 sites in 28 countries.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3Active
20212022202320242025202620272028
First PostedJul 27, 2020
Enrollment StartSep 30, 2020
Primary CompletionAug 11, 2023
Study CompletionNov 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.9 years ago

Arms & Interventions

Treatment Arm A (Open-label): Amivantamab and Lazertinibexperimental

Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\*3) orally once daily.

Drug: AmivantamabDrug: Lazertinib
Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinibactive_comparator

Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\*3) orally once daily.

Drug: OsimertinibDrug: Placebo
Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinibexperimental

Participants will receive lazertinib 240 mg (80\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

Drug: LazertinibDrug: Placebo

Interventions

Amivantamabdrug

Participants will receive amivantamab intravenously.

Osimertinibdrug

Participants will receive osimertinib capsules orally.

Lazertinibdrug

Participants will receive lazertinib tablets orally.

Placebodrug

Participants will receive matching placebo orally.