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Trial record 2 of 2 for:    NCT02609776

A Study of Lazertinib as Monotherapy or in Combination With JNJ-61186372 in Participants With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077463
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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 JNJ-61186372 (Phase 1b), to characterize the safety and tolerability of lazertinib and JNJ 61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts) and to estimate the antitumor activity of lazertinib and JNJ 61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Lazertinib Drug: JNJ-61186372 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 (monotherapy dose escalation): Lazertinib
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
Lazertinib will be administered orally.
Other Name: JNJ-73841937

Experimental: Phase 1b (combination): Lazertinib and JNJ-61186372
Participants will receive lazertinib and JNJ-61186372, 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 JNJ‑61186372 is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).
Drug: Lazertinib
Lazertinib will be administered orally.
Other Name: JNJ-73841937

Drug: JNJ-61186372
JNJ-61186372 will be administered as an intravenous infusion.

Experimental: Phase 1b (expansion): Lazertinib and JNJ-61186372
This cohort will further characterize the safety, tolerability, and preliminary antitumor activity of lazertinib and JNJ-61186372-based combinations within specific NSCLC populations who have progressed after osimertinib and platinum-based doublet chemotherapy. Participants will receive at the RP2CD of lazertinib and JNJ-61186372, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Drug: Lazertinib
Lazertinib will be administered orally.
Other Name: JNJ-73841937

Drug: JNJ-61186372
JNJ-61186372 will be administered as an intravenous infusion.




Primary Outcome Measures :
  1. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1) [ Time Frame: Until the end of first cycle (21 days for Phase 1) ]
    DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  2. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b) [ Time Frame: Until the end of first cycle (28 days for Phase 1b) ]
    DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  3. Overall Response Rate (ORR) (Phase 1b expansion) [ Time Frame: Up to 2 years ]
    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.

  4. Duration of Response (DOR) (Phase 1b expansion) [ Time Frame: Up to 2 years ]
    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.

  5. Clinical Benefit Rate (CBR) (Phase 1b expansion) [ Time Frame: Up to 2 years ]
    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.

  6. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion) [ Time Frame: Up to 2 years ]
    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 JNJ-61186372 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.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1 and Phase 1b) [ Time Frame: Up to 1.8 years ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  2. Plasma Concentration of Lazertinib (Phase 1 and Phase 1b) [ Time Frame: Up to End of Treatment [EOT]) (30 days after last dose) (up to 1.8 years) ]
    Plasma samples will be analyzed to determine concentrations of lazertinib.

  3. Serum Concentration of JNJ-61186372 (Phase 1b) [ Time Frame: Up to EOT (30 days after last dose) (up to 1.8 years) ]
    Serum samples will be analyzed to determine concentrations of JNJ-61186372.

  4. Number of Participants with Anti-drug Antibodies Against JNJ-61186372 (Phase 1b) [ Time Frame: Up to EOT (30 days after last dose) (up to 1.8 years) ]
    Number of participants with anti-drug antibodies against JNJ-61186372 will be reported.

  5. Progression free survival (PFS) (Phase 1b Expansion) [ Time Frame: Up to 1.8 years (end of treatment) ]
    PFS is defined as the time from first infusion of study intervention to PD or death due to any cause.

  6. Time to Treatment Failure (TTF) (Phase 1b Expansion) [ Time Frame: Up to 2 years ]
    TTF is defined as the time from the first administration of the study intervention to discontinuation of treatment for any reason, including disease progression, treatment toxicity, death, and will be utilized to capture clinical benefit for patients continuing treatment beyond as determined by the investigator using RECIST 1.1 criteria.

  7. Overall Survival (OS) (Phase 1b Expansion) [ Time Frame: Up to 2 years ]
    OS is defined as the time from first infusion of study intervention to death due to any cause as determined by the investigator using RECIST 1.1 criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. Phase 1b expansion Cohort A: Histologically or cytologically confirmed metastatic or unresectable EGFR-mutated NSCLC that has progressed on prior treatment with both osimertinib and platinum-doublet chemotherapy for metastatic disease. Note that the use of platinum-doublet chemotherapy in adjuvant or neo-adjuvant setting is allowed, if the last dose was administered less than 12 months prior to planned first dose of study drug
  • 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:

  • Uncontrolled intercurrent illness, including but not limited to poorly controlled diabetes, ongoing or active infection (that is, has not discontinued all antibiotics for at least one week prior to first dose of study intervention), or psychiatric illness/social situation that would limit compliance with study requirements. Participants with medical conditions requiring continuous oxygen therapy are excluded.
  • Prior treatment with antiPD-1 or anti Programmed death-ligand 1 (PD-L1) antibody within 6 weeks of planned first dose of study intervention
  • Symptomatic brain metastases or brain metastases requiring treatment. Exception: participants with asymptomatic, untreated brain metastases, each less than 1 centimetre (cm) in diameter, may be eligible for Phase 1b expansion cohorts
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <= 2 hypothyroidism stable on hormone replacement therapy)
  • Allergies, hypersensitivity, or intolerance to lazertinib (both Phase 1 and Phase 1b) and JNJ-61186372 (Phase 1b only) or their excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077463


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
Cedars Sinai Medical Center Not yet recruiting
West Hollywood, California, United States, 90048
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
United States, Oregon
Providence Portland Medical Center Not yet recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Cancer Specialists Not yet recruiting
Fairfax, Virginia, United States, 22031
Germany
Pius-Hospital Oldenburg Not yet recruiting
Oldenburg, Germany, 26121
Japan
National Cancer Center Hospital Recruiting
Chuo-ku, Japan, 104-0045
National Cancer Center Hospital East Recruiting
Kashiwa, Japan, 277-8577
Aichi Cancer Center Hospital Recruiting
Nagoya-shi, Japan, 464-8681
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-si, Korea, Republic of, 13620
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 06351
Puerto Rico
Oncologic Hospital, Puerto Rico Medical Center Not yet recruiting
Rio Piedras, Puerto Rico, OO935
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04077463    
Other Study ID Numbers: CR108656
73841937NSC1001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
2020-000747-31 ( EudraCT Number )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases