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Clinical Trials in the UK / NCT04988295
Active, not recruiting Phase 3

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

NCT04988295 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2021-11-17
Last updated
2026-08-20

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

LazertinibAmivantamabPemetrexedCarboplatin

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation * A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease * Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement) * A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study * Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8) Exclusion Criteria: * Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization * Participant with symptomatic or progressive brain metastases * Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has known small cell transformation * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis * Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Primary outcome measure(s)

Trial sites (249)

FacilityCityRegionStatus
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 the UK

Other trials for the same condition

Official registry record

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 the UK