The trial is taking place at:
C

Chris O'Brien Lifehouse | Clinical Trials

Veeva-enabled site

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 (PALOMA-3)

J

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting
Phase 3

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Treatments

Drug: Lazertinib
Drug: Amivantamab Intravenous
Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05388669
CR109211
61186372NSC3004 (Other Identifier)
2022-000525-25 (EudraCT Number)

Details and patient eligibility

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.

Enrollment

418 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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 criteria

* 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

418 participants in 2 patient groups

Arm A: Lazertinib with Amivantamab SC-CF
Experimental group
Description:
Lazertinib 240 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.
Treatment:
Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Drug: Lazertinib
Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
Experimental group
Description:
Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion.
Treatment:
Drug: Amivantamab Intravenous
Drug: Lazertinib

Trial contacts and locations

187

Loading...

Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems