A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Amivantamab: Participants will receive amivantamab intravenously.
Osimertinib: Participants will receive osimertinib capsules orally.
Lazertinib: Participants will receive lazertinib tablets orally.
Placebo: Participants will receive matching placebo orally.
Study 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).
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) — From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment.
Trial sites (269)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Goodyear | Arizona | |
| Yuma Regional Medical Center | Yuma | Arizona | |
| City of Hope Long Beach Elm | Long Beach | California | |
| University of California Irvine | Orange | California | |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | |
| Cancer Specialists of North Florida | Jacksonville | Florida | |
| University Cancer And Blood Center LLC | Athens | Georgia | |
| East Jefferson General Hospital | Metairie | Louisiana | |
| Maryland Oncology Hematology, PA | Columbia | Maryland | |
| Henry Ford Hospital | Detroit | Michigan | |
| Minnesota Oncology Hematology P A | Edina | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Washington University School Of Medicine | St Louis | Missouri | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| Texas Oncology P A | Austin | Texas | |
| Oncology Consultants Texas | Houston | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Centro Oncológico Korben | Buenos Aires | Argentina | |
| Instituto Alexander Fleming | Buenos Aires | Argentina | |
| Hospital Privado Centro Medico de Cordoba | Córdoba | Argentina | |
| Centro Oncologico Riojano Integral (Cori) | La Rioja | Argentina | |
| Clínica Viedma | Viedma | Argentina | |
| Flinders Medical Centre | Bedford Park | Australia | |
| Austin Hospital | Heidelberg | Australia | |
| Cabrini Medical Centre | Malvern | Australia | |
| St John of God Hospital Murdoch | Murdoch | Australia | |
| Sir Charles Gairdner Hospital | Nedlands | Australia | |
| Westmead Hospital | Westmead | Australia | |
| Southern Medical Day Care Centre | Wollongong | Australia | |
| Princess Alexandra Hospital | Woolloongabba | Australia | |
| Cliniques Universitaires Saint Luc | Brussels | Belgium | |
| Grand Hopital De Charleroi Site Les Viviers | Charleroi | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Clinique Saint Pierre | Ottignies | Belgium | |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | |
| Fundacao Pio XII | Barretos | Brazil | |
| Cetus Oncologia | Belo Horizonte | Brazil |
+ 229 more sites — see the full list on the official registry below.
On this site
📄 Tagrisso (osimertinib) drug profile →More Janssen Research & Development, LLC trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04487080 on ClinicalTrials.gov ↗ ← All trials in South Korea