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Clinical Trials in India / NCT04487080
Active, not recruiting Phase 3

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080 · tracked via the Priya Life Science India tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2020-09-30
Last updated
2026-08-28

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

AmivantamabOsimertinibLazertinibPlacebo

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation * The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states \[US\]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care * Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid \[ctDNA\], digital droplet polymerase chain reaction \[ddPCR\], and pharmacogenomic analysis) * Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level * Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy Exclusion Criteria: * Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease) * Participant has an active or past medical history of leptomeningeal disease * Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (\<=) 10 milligrams per day (mg/day) prednisone or equivalent * Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis * Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib * Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study

Primary outcome measure(s)

Trial sites (269)

FacilityCityRegionStatus
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 India

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 NCT04487080 on ClinicalTrials.gov ↗ ← All trials in India