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New drug combo shows promise in early lung cancer trial

NCT ID NCT04077463

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This early-phase trial is testing two experimental drugs, lazertinib and amivantamab, alone or together, in 701 people with advanced non-small cell lung cancer. The goal is to find safe doses and see if the combination can shrink tumors. Participants have already tried standard treatments.

What this could mean

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

Active substance
Lazertinib and amivantamab (drugs)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced non-small cell lung cancer that has not responded to other therapies.
What could go wrong
This is an early phase 1 trial, so safety and dosing are still being figured out. The drugs may not work well or could cause serious side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

701 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Mar 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: * Phase 1 and Phase 1b lazertinib+Amivantamab combination cohorts: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with previously epidermal growth factor receptor (EGFR) mutation (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory \[or equivalent\]) that is metastatic or unresectable, and have progressed after standard of care front-line therapy, and exhausted available options with targeted therapy. A participant who has refused all other currently available therapeutic options is allowed to enroll * For the Phase 1b Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP) combination cohort: histologically or cytologically confirmed advanced or metastatic EGFR-mutated NSCLC who have progressed on or after an EGFR-TKI as the most recent line of treatment with a maximum of 3 prior lines of therapy in the metastatic setting allowed * For all expansion cohorts, the EGFR mutation must have been previously histologically or cytologically characterized, as performed by a CLIA-certified (US sites) or an accredited (outside of US) local laboratory, with a copy of the mutation analysis being submitted during screening (Phase 1b expansion Cohort B, C, D, E, and F) 1. Expansion Cohort A: Participant must have advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) that has progressed on prior treatment with osimertinib in the first or second line, followed by progression on a platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR tyrosine kinase inhibitor (TKI) is allowed if administered prior to osimertinib 2. Expansion Cohort B: Participant must have previously treated, advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants should have been treated with standard of care, platinum-based chemotherapy regimens, but may have treated with approved EGFR TKI, investigational EGFR, or immunotherapy agents if refusing front line platinum-based chemotherapy standard of care. Up to 3 lines of prior systemic anti-cancer treatment are allowed 3. Expansion Cohort C: Participant must have advanced or metastatic NSCLC characterized by an uncommon activating mutation Additional uncommon EGFR mutations/alterations, beyond those listed above, may be considered for enrollment after agreement with the medical monitor. Participants may be treatment naïve or have been treated with one prior line of therapy which must be a first or second generation TKI (that is gefitinib, erlotinib, afatinib) in the most recent line of therapy. Prior chemotherapy is allowed if administered prior to EGFR TKI therapy, or as the only systemic anti-cancer therapy prior to study enrollment. Up to 2 lines of prior systemic anti-cancer treatment are allowed 4. Expansion Cohort D, E, and F: Participant must have advanced or metastatic EGFR-mutated NSCLC (EGFR Exon19 deletion or L858R) that has progressed on prior treatment with osimertinib in the first or second line (after first- or second-generation EGFR TKI), as the immediate prior line of therapy. Only previous treatment in the metastatic setting with a first, second, or third generation EGFR TKI is allowed. In addition, participants considered for Cohorts E and F 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 (from Day 1 through Day 120) according to national comprehensive cancer network (NCCN) or local guidelines, if assigned to the combination Cohort E * Evaluable disease * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Participants must meet the study protocol defined laboratory criteria without having a history of red blood cell transfusion, platelet transfusion, or granulocyte-colony stimulating factor support within 7 days prior to the date of the test * A woman of childbearing potential: Must have a negative serum beta human chorionic gonadotropin at screening; Must agree not to breast-feed during the study and for 6 months after the last dose of study intervention. (Enrollment is not allowed even if a woman who is breast-feeding stops breast-feeding); Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study intervention Exclusion Criteria: * Participant has an uncontrolled illness, including but not limited to uncontrolled diabetes, ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \[participants will be required to complete antibiotics 1 week prior to study treatment\] or diagnosed or suspected viral infection); active bleeding diathesis; Impaired oxygenation requiring continuous oxygen supplementation; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of study treatment; or psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements. Any ophthalmologic condition that is either clinically unstable or requires treatment * Prior treatment with anti programmed cell death-1 (PD-1) or anti programmed cell death-ligand 1 (PD-L1) antibody within 6 weeks of planned first dose of study intervention * Untreated brain or other central nervous system (CNS) metastases whether symptomatic or asymptomatic. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment may be eligible for Phase 1b expansion cohorts. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met * Any Toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<=2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement therapy) * Allergies, hypersensitivity, or intolerance to Lazertinib or JNJ-61186372 or their excipients. For the LACP combination cohort: participant has a contraindication for the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

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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

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, 464 8681, Japan

  • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

    Gauting, 82131, Germany

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • CHU De Poitiers

    Poitiers, 86000, France

  • CHU de la Timone

    Marseille, 13005, France

  • Cedars Sinai Medical Center

    West Hollywood, California, 90048, United States

  • Central Hospital of Jinan

    Jinan, 250013, China

  • Centre Leon Berard

    Lyon, 69373, France

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Evangelische Lungenklinik Berlin

    Berlin, 13125, Germany

  • H. Lee Moffitt Cancer & Research Institute

    Tampa, Florida, 33612, United States

  • HIA Begin

    Saint-Mandé, 94163, France

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28009, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hunan Cancer hospital

    Changsha, 410013, China

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • IRCCS Istituto Europeo di Oncologia

    Milan, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Kansai Medical University Hospital

    Hirakata, 573 1191, Japan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

    Cologne, 51109, Germany

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt am Main, 60590, Germany

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047, Japan

  • Langone Health at NYC University, NYU School of Medicine

    New York, New York, 10016, United States

  • Lungenklinik Hemer

    Hemer, 58675, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • National Cancer Center Hospital

    Chūōku, 104 0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Oncologic Hospital, Puerto Rico Medical Center

    Rio Piedras, OO935, Puerto Rico

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121, Italy

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

    Stuttgart, 70376, Germany

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Gerardo Hospital

    Monza, 20052, Italy

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110022, China

  • Shizuoka Cancer Center

    Shizuoka, 411 8777, Japan

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

    Halle, 06120, Germany

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 440112, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The First Bethune Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, 650101, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300000, China

  • UCSF Helen Diller Comprehensive

    San Francisco, California, 94158, United States

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Uniklinik Köln

    Cologne, 50937, Germany

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98109, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • West China School of Medicine/West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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