Evaluating amivantamab for advanced non-small cell lung cancer
Official title: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Run by Janssen Research & Development, LLC · NCT05498428 · Data updated 2026-11-12
This study is testing if a new treatment combining amivantamab and another drug can help people with advanced non-small cell lung cancer, especially those with certain genetic mutations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 520 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | amivantamab, osimertinib, lazertinib, radiation, prednisone |
| Locations | 110 sites (La Jolla, California and 109 other locations) |
| Status | Recruiting |
| Started | November 11, 2022 |
| Main results expected | August 17, 2027 |
| Study ends | August 18, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05498428 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with advanced or metastatic non-small cell lung cancer who have specific EGFR mutations and have not received prior systemic therapy or have progressed after previous treatments.
✕Probably not a fit
Patients with early-stage non-small cell lung cancer or those who have already undergone curative therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the effectiveness and safety of amivantamab, administered in combination with recombinant human hyaluronidase PH20, for patients with advanced or metastatic non-small cell lung cancer (NSCLC). Participants will be grouped based on specific genetic mutations, particularly focusing on those with EGFR mutations. The study aims to evaluate the anti-tumor activity of this treatment regimen and its safety profile across different cohorts. Various treatment combinations will be explored, including the use of other cancer therapies.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced non-small cell lung cancer, particularly those with specific EGFR mutations.
How similar studies have gone: Other studies have shown promising results with similar targeted therapies for EGFR-mutated non-small cell lung cancer, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by 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 states \[US\]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor * All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy * May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions * Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1 * Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment * A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility Exclusion Criteria: * Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis * Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort * Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary * For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1 * Other clinically active liver disease of infectious origin * Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (\>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure \>160 millimeter(s) of mercury (mmHg); diastolic blood pressure \>100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association \[NYHA\] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan * Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to \[\<=\] 10 milligrams per day \[mg/day\] prednisone or equivalent) for at least 2 weeks prior to treatment allocation
Where it's running
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University of California at San Diego
La Jolla, California, United States Recruiting -
University of California Irvine
Orange, California, United States Recruiting -
Stanford Cancer Institute
Stanford, California, United States Recruiting -
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States Recruiting -
Mount Sinai Medical Center
Miami Beach, Florida, United States Recruiting -
AdventHealth
Orlando, Florida, United States Recruiting
Show 44 more locations
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University of Kansas Cancer Center
Westwood, Kansas, United States Recruiting -
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, United States Recruiting -
Boston Medical Center
Boston, Massachusetts, United States Recruiting -
Washington University School Of Medicine
St Louis, Missouri, United States Recruiting -
Hackensack University Medical Center
Hackensack, New Jersey, United States Recruiting -
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States Recruiting -
Virginia Cancer Specialists
Fairfax, Virginia, United States Recruiting -
Swedish Cancer Institute
Seattle, Washington, United States Recruiting -
Fundacao Pio XII
Barretos, Brazil Recruiting -
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Brazil Recruiting -
Hospital do Cancer de Londrina
Londrina, Brazil Recruiting -
Hospital Moinhos de Vento
Porto Alegre, Brazil Recruiting -
IDOR - Regional Rio de Janeiro
Rio de Janeiro, Brazil Recruiting -
IDOR - Regional Bahia
Salvador, Brazil Recruiting -
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil Recruiting -
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil Recruiting -
Jilin cancer hospital
Changchun, China Recruiting -
Sichuan Cancer Hospital
Chengdu, China Recruiting -
West China Hospital Sichuan University
Chengdu, China Recruiting -
The First Affiliated Hospital of PLA Army Medical University
Chongqing, China Recruiting -
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China Recruiting -
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, China Recruiting -
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China Recruiting -
Harbin medical university cancer hospital
Harbin, China Recruiting -
Huizhou Municipal Central Hospital
Huizhou, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting -
Tianjin Medical University General Hospital
Tianjin, China Recruiting -
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China Recruiting -
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China Recruiting -
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China Recruiting -
Centre Francois Baclesse
Caen, France Recruiting -
Institut de Cancérologie du Gard
Nîmes, France Recruiting -
Institut Curie
Paris, France Recruiting -
Institut de cancerologie de l'ouest
Saint-Herblain, France Recruiting -
Gustave Roussy
Villejuif, France Recruiting -
Universitaetsklinikum Koeln
Cologne, Germany Recruiting -
LungenClinic Grosshansdorf GmbH
Grosshandorf, Germany Recruiting -
Lungenfachklinik Immenhausen
Immenhausen, Germany Recruiting -
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, Germany Recruiting -
Rambam Medical Center
Haifa, Israel Recruiting -
Shaare Zedek Medical Center
Jerusalem, Israel Recruiting -
Rabin Medical Center
Petah Tikva, Israel Recruiting -
Sheba Medical Center
Ramat Gan, Israel Recruiting -
Policlinico Hospital San Martino- IRCCS for Oncology
Genova, Italy Recruiting
+60 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC
This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.
-
Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.
This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.
-
Amivantamab plus olomorasib for metastatic KRAS G12C non-small cell lung cancer
This trial tests whether combining amivantamab and olomorasib can slow tumor growth in people with metastatic non-small cell lung cancer that has a KRAS G12C mutation after platinum chemotherapy and PD‑L1 immunotherapy.
-
Combining Amivantamab with Lazertinib or Chemotherapy for Advanced Lung Cancer
This study tests if a new combination of amivantamab with lazertinib or chemotherapy can help people with advanced lung cancer that has certain genetic changes.
-
Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma
This study tests whether giving amivantamab with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung cancer.
-
Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer
This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.