Lazertinib
DrugLazertinib tablets will be administered orally.
Other names: JNJ-73841937, YH25448
NCT Number: NCT05388669
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
CEMIC (Centro de Educación Médica e Investigaciones Clínicas), Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lazertinib tablets will be administered orally.
Other names: JNJ-73841937, YH25448
Amivantamab injection will be administered subcutaneously by manual injection.
Other names: JNJ-61186372
Amivantamab will be administered by IV infusion.
Other names: JNJ-61186372
Time frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Time frame: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
Time frame: 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
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
Time frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Time frame: Cycle 4: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hrs post-dose on Day 1; Arm B: preinfusion, EOI+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: From baseline (Day 1, Cycle 1) to 3 years 4 months (each cycle of 28 days)
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Time frame: Up to 3 years 4 months
Janssen Research & Development, LLC
Industry
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
Acronym: PALOMA-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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