Clinical Trials /

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

NCT04077463

Description:

The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of lazertinib (Phase 1) and to determine the tolerability and identify the recommended Phase 2 combination dose of lazertinib when combined with JNJ-61186372 (Phase 1b) in Japanese participants.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Lazertinib as Monotherapy or in Combination With JNJ-61186372 in Japanese Participants With Advanced Non-small Cell Lung Cancer
  • 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 Combination With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Japanese Participants With Advanced Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: CR108656
  • SECONDARY ID: 73841937NSC1001
  • NCT ID: NCT04077463

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
LazertinibJNJ-73841937Phase 1 (monotherapy dose escalation): Lazertinib
JNJ-61186372Phase 1b (combination): Lazertinib and JNJ-61186372

Purpose

The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of lazertinib (Phase 1) and to determine the tolerability and identify the recommended Phase 2 combination dose of lazertinib when combined with JNJ-61186372 (Phase 1b) in Japanese participants.

Trial Arms

NameTypeDescriptionInterventions
Phase 1 (monotherapy dose escalation): LazertinibExperimentalParticipants 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).
  • Lazertinib
Phase 1b (combination): Lazertinib and JNJ-61186372ExperimentalParticipants 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).
  • Lazertinib
  • JNJ-61186372

Eligibility 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

          -  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, 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

          -  Symptomatic brain metastases or brain metastases requiring treatment

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure: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
Safety Issue:
Description: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.
Measure: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)
Safety Issue:
Description:Plasma samples will be analyzed to determine concentrations of lazertinib.
Measure:Serum Concentration of JNJ-61186372 (Phase 1b)
Time Frame:Up to EOT (30 days after last dose) (up to 1.8 years)
Safety Issue:
Description:Serum samples will be analyzed to determine concentrations of JNJ-61186372.
Measure: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)
Safety Issue:
Description:Number of participants with anti-drug antibodies against JNJ-61186372 will be reported.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Pharmaceutical K.K.

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