Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

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

Keywords

Carcinoma, Non-Small-Cell Lung Lazertinib JNJ-61186372

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Helen Diller Comprehensive not yet accepting patients
    San Francisco California 94115 United States
  • Standford University not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT04077463
Phase
Phase 1
Study Type
Interventional
Last Updated