Lazertinib
DrugLazertinib will be administered orally.
Other names: JNJ-73841937, YH-25448
NCT Number: NCT04988295
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
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), CABA, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lazertinib will be administered orally.
Other names: JNJ-73841937, YH-25448
Amivantamab will be administered as an IV infusion.
Other names: JNJ-61186372
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
Time frame: From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum).
Time frame: up to 4 years 10 months
Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Time frame: Up to 4 years 10 months
Janssen Research & Development, LLC
Industry
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
Acronym: MARIPOSA-2
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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