A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: CR10865673841937NSC10012020-000747-312023-506577-35-00
• Study Type: interventional
• Target: 701
• Locations: 10 countries
• Sites: 78

Brief Summary

The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1)

  DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  Until the end of first cycle (21 days for Phase 1)

• Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b)

  DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  Until the end of first cycle (28 days for Phase 1b)

• Overall Response Rate (ORR) (Phase 1b Expansion Cohorts A-D)

  ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria.

  Up to 2.5 years

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion Cohorts A-E)

  Adverse events (AEs) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Criteria Version 5.0 in participants treated at the RP2CD regimen of Lazertinib and Amivantamab combination therapy. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to 2.5 years

• Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP])

  DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  Until the end of first cycle (21 days for Phase 1b combination LACP)

• Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP)

  AEs defined by the NCI-CTCAE criteria version 5.0 in participants treated with LACP combination regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to 2.5 years

• Overall Response Rate (ORR) per RECIST version 1.1 (v1.1) with NGS Analysis of Circulating Tumor ctDNA, IHC Analysis of EGFR and MET Expression (Phase 1b Expansion Cohort D)

  ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria with Next Generation Sequencing (NGS) Analysis of Circulating Tumor Deoxyribonucleic Acid (ctDNA), Immunohistochemical (IHC) Analysis of Tumor Epidermal Growth Factor Receptor (EGFR) and MET Expression (Phase 1b Expansion Cohort D).

  Up to 2.5 years

• ORR Among Participants with MET3+ Staining on Greater Than or Equal to (>=)25 Percent (%) of Tumor Cells (Phase 1b Expansion Cohorts E and F)

  ORR among participants with MET3+ staining on \>=25 % of tumor cells will be reported. ORR is defined as the percentage of participants who achieve either a CR or PR as determined by the investigator using RECIST 1.1 criteria.

  Up to 2.5 years

• Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)

  DOR among participants with MET3+ staining on \>=25 % of tumor cells will be reported. DOR will be calculated as time from initial response of CR or PR to progressive disease (PD) or death due to any cause, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST 1.1 criteria.

  Up to 2.5 years

• Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)

  CBR among participants with MET3+ staining on \>=25% of tumor cells will be reported. CBR is defined as the percentage of participants achieving complete or partial response, or durable stable disease (duration of at least 11 weeks) as determined by the investigator using RECIST 1.1 criteria.

  Up to 2.5 years

Secondary Outcomes (15)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1 and Phase 1b)

  Up to 2.5 years

• Plasma Concentration of Lazertinib (Phase 1 and Phase 1b)

  Up to End of Treatment [EOT]) (30 days after last dose) (up to 2.5 years)

• Serum Concentration of Amivantamab (Phase 1b)

  Up to EOT (30 days after last dose) (up to 2.5 years)

• Number of Participants with Anti-drug Antibodies Against Amivantamab (Phase 1b)

  Up to EOT (30 days after last dose) (up to 2.5 years)

• Progression free survival (PFS) (Phase 1b Expansion)

  Up to 2.5 years

Study Arms (9)

Phase 1 (monotherapy dose escalation): Lazertinib

EXPERIMENTAL

Participants will receive Lazertinib monotherapy orally once daily (QD) in 21-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. The subsequent doses of Lazertinib will be assigned by the Study Evaluation Team (SET) according to the dose escalation strategy by Bayesian logistic regression model (BLRM).

Drug: Lazertinib

Phase 1b (combination): Lazertinib and Amivantamab

EXPERIMENTAL

Participants will receive Lazertinib and Amivantamab, after the safety of RP2D of Lazertinib is confirmed in the Phase 1, in 28-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. This phase will start enrolling participants after the safety of Amivantamab is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)

EXPERIMENTAL

Participants will receive Lazertinib starting dose administered orally once daily (QD) in combination with Amivantamab, and doses of platinum-based chemotherapy (carboplatin and pemetrexed) per standard of care according to local guidance in a 21-day cycle for 4 cycles followed by maintenance with Lazertinib, Amivantamab and pemetrexed until disease progression or unacceptable toxicities.

Drug: Lazertinib; Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab

EXPERIMENTAL

This cohort A will further characterize the safety, tolerability, and preliminary antitumor activity of Lazertinib and Amivantamab based combinations within specific NSCLC population "who have progressed after osimertinib and subsequent platinum-based chemotherapy, and platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR TKI is allowed if administered prior to osimertinib. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab

EXPERIMENTAL

This Cohort B will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants previously treated with advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab

EXPERIMENTAL

This Cohort C will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants with uncommon EGFR mutations. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab

EXPERIMENTAL

Cohort D will seek to validate one or both potential biomarker strategies (next generation sequencing \[NGS\] and Immunohistochemical \[IHC\]), previously identified in Cohort E of Study 61186372EDI1001, in participants with osimertinib-relapsed, but chemotherapy-naive, EGFR Exon19del or L858R mutated NSCLC. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab

EXPERIMENTAL

Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter. Cohort E will seek to validate the immunohistochemical (IHC)-based biomarker strategy, by characterizing the activity of Amivantamab and Lazertinib combination in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC. In addition, Cohort E will seek to collect prospective data to confirm that prophylactic anticoagulation safely and effectively decreases the incidence of VTE events for patients treated with the combination of Amivantamab and Lazertinib, using Cohort F as reference.

Drug: Lazertinib; Drug: Amivantamab

Phase 1b (expansion) Cohort F: Amivantamab Monotherapy

EXPERIMENTAL

Participants will receive Amivantamab monotherapy once weekly (QW) for 4 weeks, then every 2 weeks thereafter. Cohort F will seek to validate the IHC-based biomarker strategy, previously identified in Cohort D, by characterizing the activity of JNJ-61186372 monotherapy (Cohort F) in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC.

Drug: Amivantamab

Interventions

Lazertinib DRUG

Lazertinib will be administered orally.

Also known as: JNJ-73841937

Phase 1 (monotherapy dose escalation): Lazertinib; Phase 1b (combination): Lazertinib and Amivantamab; Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP); Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab

Amivantamab DRUG

Amivantamab will be administered as an intravenous (IV) infusion.

Also known as: JNJ-61186372

Phase 1b (combination): Lazertinib and Amivantamab; Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP); Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab; Phase 1b (expansion) Cohort F: Amivantamab Monotherapy

Carboplatin DRUG

Carboplatin will be administered as IV infusion.

Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)

Pemetrexed DRUG

Pemetrexed will be administered as IV infusion.

Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (78)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

UCSF Helen Diller Comprehensive

San Francisco, California, 94158, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Cedars Sinai Medical Center

West Hollywood, California, 90048, United States

Location

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Langone Health at NYC University, NYU School of Medicine

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The First Bethune Hospital of Jilin University

Changchun, 130021, China

Location

Hunan Cancer hospital

Changsha, 410013, China

Location

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

Chengdu, 610041, China

Location

Chongqing University Cancer Hospital

Chongqing, 400030, China

Location

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, 440112, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Central Hospital of Jinan

Jinan, 250013, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, 650101, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110022, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300000, China

Location

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

Wuhan, 430022, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13005, France

Location

Institut Curie

Paris, 75005, France

Location

CHU De Poitiers

Poitiers, 86000, France

Location

HIA Begin

Saint-Mandé, 94163, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Kliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

Cologne, 51109, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Gauting, 82131, Germany

Location

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 06120, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

Stuttgart, 70376, Germany

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

IRCCS Istituto Europeo di Oncologia

Milan, Italy

Location

San Gerardo Hospital

Monza, 20052, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy

Location

Ospedale S. Maria Delle Croci

Ravenna, 48121, Italy

Location

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

Kansai Medical University Hospital

Hirakata, 573 1191, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650 0047, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464 8681, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411 8777, Japan

Location

Oncologic Hospital, Puerto Rico Medical Center

Rio Piedras, OO935, Puerto Rico

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp. Univ. Quiron Dexeus

Barcelona, 08028, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28009, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lazertinib; amivantamab; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: September 4, 2019
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): March 27, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (7); CN (14); JP (7); ES (8); PR (1); KR (4); US (18); TW (4); DE (10); IT (5)