Trial Search Results

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

This study has three parts (Phase 1, a Phase 1b combination cohortand a Phase 1b expansion cohort). Stanford will take part in theexpansion cohort only. The expansion cohort will look at the effectthat lazertinib and JNJ-61186372 in combination have on lung cancerand any side effects.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Janssen Research & Development, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Lazertinib
  • Drug: Amivantamab
  • Drug: Carboplatin
  • Drug: Pemetrexed

Phase:

Phase 1

Eligibility


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 and D)

      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 na├»ve 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: 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

   - 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 uncontrolled
   diabetes, ongoing or active infection (includes infection requiring treatment with
   antimicrobial therapy [participants will be required to complete antibiotics 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 antiPD-1 or anti Programmed 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richard Quick
650-723-2983
Recruiting