A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
Lazertinib: Lazertinib will be administered orally.
Amivantamab: Amivantamab will be administered as an IV infusion.
Pemetrexed: Pemetrexed will be administered as an IV infusion.
Carboplatin: Carboplatin will be administered as an IV infusion.
Study summary
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Eligibility
Primary outcome measure(s)
- Main Study: 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 occurred first (up to 1 year 7 months)
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter (mm) from nadir (including baseline if it was smallest sum). - Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — up to 4 years 10 months
Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion. - Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review — Up to 4 years 10 months
Trial sites (249)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center, PC | Mobile | Alabama | |
| Arizona Oncology Associates | Tucson | Arizona | |
| City of Hope | Duarte | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| University of California Irvine | Orange | California | |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | |
| Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | |
| University Cancer And Blood Center LLC | Athens | Georgia | |
| University of Mississippi Medical Center | Jackson | Mississippi | |
| Nebraska Cancer Specialists | Grand Island | Nebraska | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| TriHealth Network | Cincinnati | Ohio | |
| Providence Portland Medical Center | Portland | Oregon | |
| Kaiser Permanente Northwest | Portland | Oregon | |
| Alliance Cancer Specialists | Horsham | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Baptist Cancer Center | Memphis | Tennessee | |
| Texas Oncology-Medical City Dallas | Dallas | Texas | |
| Texas Oncology Baylor Charles A Sammons Cancer Center | Dallas | Texas | |
| Texas Oncology | Grapevine | Texas | |
| Oncology Consultants Texas | Houston | Texas | |
| Texas Oncology - Northeast | Longview | Texas | |
| University of Vermont Medical Center | Burlington | Vermont | |
| University of Virginia | Charlottesville | Virginia | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Blue Ridge Cancer Care | Wytheville | Virginia | |
| NorthWest Medical Specialties, PLLC | Puyallup | Washington | |
| Compass Oncology | Vancouver | Washington | |
| CINME Centro de Investigaciones Metabolicas | Caba | Argentina | |
| IADT Instituto Argentino de Diagnostico y Tratamiento | CABA | Argentina | |
| Centro Medico Fleischer | CABA | Argentina | |
| CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | CABA | Argentina | |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | Argentina | |
| Hospital Privado Universitario De Cordoba | Córdoba | Argentina | |
| Hospital Privado de la Comunidad | Mar del Plata | Argentina | |
| Clínica Viedma | Viedma | Argentina | |
| Grand Hopital De Charleroi Site Les Viviers | Charleroi | Belgium | |
| UZA | Edegem | Belgium | |
| UZ Gent | Ghent | Belgium | |
| Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | Belgium |
+ 209 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
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 NCT04988295 on ClinicalTrials.gov ↗ ← All trials in Italy