7 JCI-accredited hospitals 17 hospitals with oncology 65 oncology specialists 19 clinical trials recruiting
Oncology & Cancer Care
Active, closed to enrolmentPhase 3NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Amivantamab is usually given by intravenous infusion, which takes several hours. This study tests a new under-the-skin (subcutaneous) form given with lazertinib in people with EGFR-mutated lung cancer to see if it works as well and is easier to receive.

SponsorJanssen Research & Development, LLC
Study typeInterventional
Started2022-08-05
Primary completion2024-01-03
Planned enrolment418
Sites1 Acıbadem · 186 other

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

What this study is about

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Conditions
  • Advanced or Metastatic Non-small Cell Lung Cancer
Interventions
  • Lazertinib
  • Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
  • Amivantamab Intravenous
Primary outcome measures
  • For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State — Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
  • For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab — Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
  • Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2 — Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
* Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US) * Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease * Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1 * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 * Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to (\<=) 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement)
Exclusion
* Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors * Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization * Participant has symptomatic or progressive brain metastases * Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has uncontrolled tumor-related pain * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Maslak Hospital, Istanbul

Also running at 186 other sites in 20 countries.

Source: ClinicalTrials.gov NCT05388669 · last updated 2026-08-31 · View registry record ↗