A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3)
A Phase 3, Open-Label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Subcutaneous Amivantamab Administered via On-Body Delivery System in Patients with EGFR-Mutated Advanced or Metastatic NonSmall Cell Lung Cancer After Progression on Osimertinib and Chemotherapy (PALOMA-3)
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Clinical Trial Information
Trial Contact: Casillas, Bridey L; Ribacchi, Stephanie; Durand, Jennifer
Trial Phone: 321.841.8284 ; 321-841-1077 ; 321.843.2026
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IRB No: W22.259.12/20223894
Protocol Abbrev: PALOMA-3
Principal Investigator: Tirrell Tremayne Johnson, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: 61186372NSC3004
Treatment: Part1 Arm A1: Drug: Lazertinib Lazertinib tablets will be administered orally. Other Names: JNJ-73841937 YH25448 Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) Amivantamab injection will be administered subcutaneously by manual injection Other Name: JNJ-61186372 Part 1; Arm: B1 Drug: Lazertinib Lazertinib tablets will be administered orally. Other Names: JNJ-73841937 YH25448 Drug: Amivantamab Intravenous Amivantamab will be administered by IV infusion Other Name: JNJ-61186372 Part 2: Arm A2: Drug: Lazertinib Lazertinib tablets will be administered orally. Other Names: JNJ-73841937 YH25448 Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) Amivantamab injection will be administered subcutaneously by manual injection Other Name: JNJ-61186372 Part 2: Arm B2: Drug: Lazertinib Lazertinib tablets will be administered orally. Other Names: JNJ-73841937 YH25448 Device: Amivantamab SC-CF On-Body Delivery System (OBDS) Amivantamab will be administered by subcutaneously by OBDS Other Name: JNJ-61186372
ClinicalTrials.gov ID: NCT05388669
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Objective
Primary Objective(s):
Part 1: To assess the noninferiority of amivantamab SC-CF
administered via manual injection (Arm A1) versus
amivantamab IV (Arm B1)
Part 2: To assess the bioequivalence of amivantamab SC-CF
administered via manual injection (Arm A2) and amivantamab
SC-CF OBDS (Arm B2) -
Key Eligibility
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
