Lung cancer drug gets a shot in the arm: new subcutaneous formula tested

NCT ID NCT05498428

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 2 trial is testing amivantamab, a targeted cancer drug, given as a simple shot under the skin (instead of an IV drip) in people with advanced non-small cell lung cancer that has specific EGFR mutations. The study will enroll about 520 participants across several groups, combining amivantamab with other drugs like lazertinib or chemotherapy. The main goals are to see how well the drug shrinks tumors and to check its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: amivantamab (a targeted cancer drug) given as a shot under the skin, often combined with other drugs like lazertinib, carboplatin, or pemetrexed
What this could lead to: If successful, this could offer a more convenient way to deliver amivantamab (as a shot instead of an IV infusion) and improve tumor shrinkage in people with advanced lung cancer.
What could go wrong: This is a phase 2 trial, so it's still early. The drug may not work as well as hoped, and side effects (like infusion reactions or blood clots) are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 520 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

82 sites in 11 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

ASST Grande Ospedale Metropolitano Niguarda
RECRUITING

Milan, 20162, Italy
AdventHealth
RECRUITING

Orlando, Florida, 32804, United States
Affiliated Hospital of Hebei University
COMPLETED

Baoding, 071051, China
Asan Medical Center
COMPLETED

Seoul, 05505, South Korea
Azienda Ospedaliera San Gerardo
RECRUITING

Monza, 20090, Italy
Azienda Ospedaliera Specialistica dei Colli
RECRUITING

Naples, 80131, Italy
Baptist Lynn Cancer Institute
COMPLETED

Boca Raton, Florida, 33486, United States
Beacon Hospital Sdn Bhd
RECRUITING

Petaling Jaya, 46050, Malaysia
Boston Medical Center
RECRUITING

Boston, Massachusetts, 02118, United States
Centre Francois Baclesse
RECRUITING

Caen, 14076, France
Centre Georges-François Leclerc
COMPLETED

Dijon, 21079, France
Cheltenham General Hospital
COMPLETED

Cheltenham, GL53 7AN, United Kingdom
Cleveland Clinic
COMPLETED

Cleveland, Ohio, 44195, United States
Cleveland Clinic 1
COMPLETED

Cleveland, Ohio, 44111, United States
Cleveland Clinic 2
COMPLETED

Mayfield Heights, Ohio, 44124, United States
Cleveland Clinic 3
COMPLETED

Warrensville Heights, Ohio, 44122, United States
Edinburgh Cancer Centre Western General
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Evangelische Lungenklinik Berlin
COMPLETED

Berlin, 13125, Germany
Fudan University Shanghai Cancer Center
RECRUITING

Shanghai, 200032, China
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING

São Paulo, 01509 900, Brazil
Fundacao Pio XII
RECRUITING

Barretos, 14784-400, Brazil
General University Hospital of Alicantet
RECRUITING

Alicante, 03010, Spain
Gustave Roussy
RECRUITING

Villejuif, 94800, France
H. Lee Moffitt Cancer & Research Institute
COMPLETED

Tampa, Florida, 33612, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Harbin medical university cancer hospital
RECRUITING

Harbin, 150000, China
Hematology-Oncology Associates of CNY
COMPLETED

East Syracuse, New York, 13057, United States
Hosp Regional Univ de Malaga
RECRUITING

Málaga, 29010, Spain
Hosp Univ A Coruna
RECRUITING

A Coruña, 15006, Spain
Hosp Univ Vall D Hebron
RECRUITING

Barcelona, 08035, Spain
Hosp. Clinico Univ. de Valencia
RECRUITING

Valencia, 46010, Spain
Hosp. Del Mar
RECRUITING

Barcelona, 08003, Spain
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING

Madrid, 28007, Spain
Hosp. Gral. Univ. Valencia
RECRUITING

Valencia, 46014, Spain
Hosp. Univ. 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hosp. Univ. La Paz
RECRUITING

Madrid, 28046, Spain
Hosp. Univ. Ramon Y Cajal
RECRUITING

Madrid, 28034, Spain
Hosp. Virgen Macarena
RECRUITING

Seville, 41009, Spain
Hosp. de La Santa Creu I Sant Pau
RECRUITING

Barcelona, 08025, Spain
Hospital Alemao Oswaldo Cruz
RECRUITING

São Paulo, 01327 001, Brazil
Hospital Moinhos de Vento
RECRUITING

Porto Alegre, 90035-001, Brazil
Hospital Tengku Ampuan Afzan
RECRUITING

Kuantan, 25100, Malaysia
Hospital Umum Sarawak
RECRUITING

Kuching, 93586, Malaysia
Hospital do Cancer de Londrina
RECRUITING

Londrina, 86015 520, Brazil
Hospital of Jiangnan University
COMPLETED

Wuxi, 214122, China
Huizhou Municipal Central Hospital
RECRUITING

Huizhou, 516001, China
IDOR - Regional Bahia
RECRUITING

Salvador, 41253-190, Brazil
IDOR - Regional Rio de Janeiro
RECRUITING

Rio de Janeiro, 22281 100, Brazil
Impar Servicos Hospitalares SA Hospital Nove de Julho
COMPLETED

São Paulo, 01409-001, Brazil
Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING

Barcelona, 8908, Spain
Institut Curie
RECRUITING

Paris, 75248, France
Institut de Cancérologie du Gard
RECRUITING

Nîmes, 30029, France
Institut de cancerologie de l'ouest
RECRUITING

Saint-Herblain, 44805, France
Jilin cancer hospital
RECRUITING

Changchun, 130000, China
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
RECRUITING

Würzburg, 97074, Germany
Leicester Royal Infirmary
RECRUITING

Leicester, LE1 5WW, United Kingdom
Liuzhou people's Hospital
COMPLETED

Liuzhou, 545006, China
LungenClinic Grosshansdorf GmbH
RECRUITING

Grosshandorf, 22927, Germany
Lungenfachklinik Immenhausen
RECRUITING

Immenhausen, 34376, Germany
Meir Medical Center
COMPLETED

Kfar Saba, 44281, Israel
Mount Sinai Medical Center
RECRUITING

Miami Beach, Florida, 33140, United States
National Cancer Center
RECRUITING

Goyang-si, 10408, South Korea
National Hospital Organization Himeji Medical Center
ACTIVE_NOT_RECRUITING

Himeji, 670-8520, Japan
Niigata Cancer Center Hospital
ACTIVE_NOT_RECRUITING

Niigata, 951-8566, Japan
Nottingham City Hospital
RECRUITING

Nottingham, NG5 1PB, United Kingdom
Novant Health
COMPLETED

Winston-Salem, North Carolina, 27106, United States
Novant Health 1
COMPLETED

Charlotte, North Carolina, 28204, United States
Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy
PERSONAL Oncologia de Precisao e Personalizada
RECRUITING

Belo Horizonte, 30130 090, Brazil
Policlinico Hospital San Martino- IRCCS for Oncology
RECRUITING

Genova, 16132, Italy
Providence Regional Cancer Partnership
COMPLETED

Everett, Washington, 98201, United States
Queen Alexandra Hospital
RECRUITING

Portsmouth, PO6 3LY, United Kingdom
Rabin Medical Center
RECRUITING

Petah Tikva, 4941492, Israel
Rambam Medical Center
RECRUITING

Haifa, 3109601, Israel
Rutgers Cancer Institute of New Jersey
RECRUITING

New Brunswick, New Jersey, 08901, United States
Saiseikai Matsusaka Municipal Hospital
ACTIVE_NOT_RECRUITING

Matsusaka, 515 8544, Japan
Seoul National University Bundang Hospital
RECRUITING

Seongnam-si, 13620, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Shaare Zedek Medical Center
RECRUITING

Jerusalem, 9103102, Israel
Sheba Medical Center
RECRUITING

Ramat Gan, 52621, Israel
Shizuoka Cancer Center
ACTIVE_NOT_RECRUITING

Shizuoka, 411 8777, Japan
Sichuan Cancer Hospital
RECRUITING

Chengdu, 610041, China
Sidney Kimmel Cancer Center - Bayview Campus
RECRUITING

Baltimore, Maryland, 21224, United States
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING

Hangzhou, 310016, China
Stanford Cancer Institute
RECRUITING

Stanford, California, 94305, United States
Swedish Cancer Institute
RECRUITING

Seattle, Washington, 98104, United States
The Cancer Institute Hospital of JFCR
ACTIVE_NOT_RECRUITING

Tokyo, 135 8550, Japan
The First Affiliated Hospital Sun Yat sen University
RECRUITING

Guangzhou, 510060, China
The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING

Hangzhou, 310003, China
The First Affiliated Hospital of PLA Army Medical University
RECRUITING

Chongqing, 400038, China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, 325000, China
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING

Xi'an, 710061, China
The Huntsman Cancer Institute
COMPLETED

Salt Lake City, Utah, 84112, United States
Tianjin Medical University General Hospital
RECRUITING

Tianjin, 300052, China
Torbay Hospital-Devon
RECRUITING

Devon, TQ2 7AA, United Kingdom
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING

Wuhan, 430022, China
Universitaetsklinikum Koeln
RECRUITING

Cologne, 50937, Germany
University College London Hospitals
RECRUITING

London, NW1 2PG, United Kingdom
University Malaya Medical Centre
RECRUITING

Kuala Lumpur, 59100, Malaysia
University of California Irvine
RECRUITING

Orange, California, 92868, United States
University of California at San Diego
RECRUITING

La Jolla, California, 92093, United States
University of Kansas Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
Virginia Mason Medical Center
COMPLETED

Seattle, Washington, 98101, United States
Wakayama Medical University Hospital
ACTIVE_NOT_RECRUITING

Wakayama, 641 8510, Japan
Washington University School Of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West China Hospital Sichuan University
RECRUITING

Chengdu, 610047, China
Yantai Yuhuangding Hospital
COMPLETED

Yantai, 264000, China

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