Amivantamab
DrugAmivantamab will be administered.
Other names: JNJ-61186372
NCT Number: NCT06667076
The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Ziekenhuis Oost-Limburg, Genk, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amivantamab will be administered.
Other names: JNJ-61186372
Lazertinib tablet will be administered.
Other names: JNJ-73841937
Pemetrexed will be administered.
Carboplatin will be administered.
Time frame: Up to 4 Years and 6 months
PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.
Time frame: Up to 4 Years and 6 months
Participants with dose reductions, interruptions, and discontinuations will be reported.
Time frame: Up to 4 Years and 6 months
Participants with signs and symptoms (dyspnea, tachypnea, upper- or lower-extremity swelling and discoloration) of VTE events, specifically pulmonary embolism, and deep vein thrombosis will be reported as monitored by the investigators.
Time frame: Up to 4 Years and 6 months
Participants with dermatologic AEs will be reported.
Time frame: Up to 4 Years and 6 months
Severity of AEs will be graded according to the national cancer institute common terminology criteria for adverse event (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
Time frame: Up to 4 Years and 6 months
OS is defined as the time from the date of first dose of any study treatment until the date of death due to any cause.
Time frame: Up to 4 Years and 6 months
ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR) as their best response both confirmed and unconfirmed, as defined using RECIST v1.1.
Time frame: Up to 4 Years and 6 months
CBR is defined as the percentage of participants achieving CR or PR, both confirmed and unconfirmed, or durable stable disease (SD) of a duration of at least 11 weeks as defined using RECIST v1.1.
Time frame: Up to 4 Years and 6 months
DOR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever occurs first, for participants who have PR or CR.
Time frame: Up to 4 Years and 6 months
TTTD is defined as the date from the date of first dose of any study treatment until discontinuation of study treatment for any reason, including disease progression, treatment toxicity or death, based on RECIST v 1.1.
Time frame: Up to 4 Years and 6 months
TTST is defined as the time from the date of first dose of any study treatment until the start date of the subsequent anticancer therapy following study treatment discontinuation or death, whichever occurs first.
Time frame: Up to 4 Years and 6 months
TTSP is defined as the time from date of first dose of any study treatment to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in systemic anticancer treatment and/or clinical intervention to manage symptoms or death.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Acronym: COPERNICUS
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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