> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-amivantamab-in-combination-with-lazertinib-or-811742ea-fa47-4825-bf2b-6fdcf23f2f3b > Record changed: 2026-10-13 # A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) NCT06667076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Participants 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Start date 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) Number of sites 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Acronym** COPERNICUS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Short title** A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Dates **Completion date** 2030-12-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **First posted** 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Primary completion date** 2029-05-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Start date** 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Size and sites **Participants** 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Planned participants** 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Number of sites** 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Identifiers **Registry ID** NCT06667076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **ClinicalTrials.gov ID** NCT06667076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Outcomes ### Primary outcomes 1. Progression Free Survival (PFS) Timeframe: 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. ### Secondary outcomes 1. Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations Timeframe: Up to 4 Years and 6 months Participants with dose reductions, interruptions, and discontinuations will be reported. 2. Number of Participants With Venous Thromboembolic Events (VTEs) Timeframe: 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. 3. Number of Participants With Dermatologic Adverse Events (AEs) Timeframe: Up to 4 Years and 6 months Participants with dermatologic AEs will be reported. 4. Number of Participants with AEs by Severity Timeframe: 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. 5. Overall Survival (OS) Timeframe: 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. 6. Overall Response Rate (ORR) Timeframe: 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. 7. Clinical Benefit Rate (CBR) Timeframe: 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. 8. Duration of Response (DOR) Timeframe: 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. 9. Time to Treatment Discontinuation (TTTD) Timeframe: 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. 10. Time to Subsequent Therapy (TTST) Timeframe: 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. 11. Time to Symptomatic Progression (TTSP) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy - Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended - Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated - Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement) - Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 ### Exclusion criteria - Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis - Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study - Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing) - Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study - Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Sites - Southern Cancer Center, PCDaphne, United StatesRecruiting - Clearview Cancer InstituteHuntsville, United StatesRecruiting - City of Hope PhoenixGoodyear, United StatesRecruiting - The Oncology Institute of Hope and InnovationCerritos, United StatesRecruiting - City of Hope CoronaCorona, United StatesRecruiting - City of HopeDuarte, United StatesRecruiting - Providence Medical FoundationFullerton, United StatesRecruiting - Oncology Physicians Network HealthcareGlendale, United StatesCompleted - Los Angeles Cancer NetworkGlendale, United StatesRecruiting - Glendale Adventist Medical CenterGlendale, United StatesRecruiting - Marin Cancer CenterGreenbrae, United StatesRecruiting - City of Hope SeacliffHuntington Beach, United StatesRecruiting - City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesRecruiting - University of California San Diego HealthLa Jolla, United StatesRecruiting - City of Hope Antelope ValleyLancaster, United StatesRecruiting - City of Hope Long Beach ElmLong Beach, United StatesRecruiting - Cancer and Blood Specialty ClinicLos Alamitos, United StatesRecruiting - USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - Cedars Sinai Medical CenterLos Angeles, United StatesRecruiting - Valkyrie Clinical TrialsLos Angeles, United StatesRecruiting - Valkyrie Clinical Trials MurrietaMurrieta, United StatesRecruiting - Kaiser Permanente Oakland Medical CenterOakland, United StatesCompleted - St. Joseph Hospital Center for Cancer Prevention and TreatmentOrange, United StatesRecruiting - University of California IrvineOrange, United StatesRecruiting - Sutter Health Palo Alto Medical FoundationPalo Alto, United StatesRecruiting And 178 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## References ### Other registry identifiers (3) - 2025 - 2025-520730-28-00 - 61186372NSC2012 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06667076) ## Related records ### Drugs (4) - [Amivantamab](https://trialight.com/data/asset/amivantamab-94d99890-d90e-4d89-8a02-036a29458456.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Lazertinib mesylate](https://trialight.com/data/asset/lazertinib-mesylate-6e43140e-9e73-4520-9ea0-544e8808c3bb.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (5) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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