Clinical Trials /

Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations

NCT03805841

Description:

Open-label, Phase 2, single treatment arm, 2 cohorts

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations
  • Official Title: A Phase 2 Study to Evaluate the Objective Response to Tarloxotinib Administered Intravenously to Patients With Non Small Cell Lung Cancer That Harbors Either EGFR Exon 20 Insertion or a HER2-Activating Mutation

Clinical Trial IDs

  • ORG STUDY ID: RAIN-701
  • NCT ID: NCT03805841

Conditions

  • NSCLC, Stage IV
  • NSCLC Stage IIIB
  • NSCLC, Stage IIIC
  • NSCLC, Recurrent
  • EGFR Exon 20 Insertion Mutation
  • HER2-activating Mutation

Interventions

DrugSynonymsArms
tarloxotinib bromideTarlox, tarloxotinibActive

Purpose

Open-label, Phase 2, single treatment arm, 2 cohorts

Trial Arms

NameTypeDescriptionInterventions
ActiveExperimentaltarloxotinib bromide
  • tarloxotinib bromide

Eligibility Criteria

        Key Inclusion Criteria:

          -  Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV,
             Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent
             disease after prior diagnosis of Stage I-III disease

          -  Progression of disease on or after a platinum-based chemotherapy regimen

          -  EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B)

          -  Measurable disease according to RECIST v.1.1

          -  ECOG performance status of 0 or 1

          -  Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using
             Cockcroft Gault equation)

          -  Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤
             5 x ULN, in the presence of liver metastases

          -  Absolute neutrophil count (ANC) ≥ 1,500 cells/μL

          -  Hemoglobin ≥ 9 g/dL or 5.6 mmol/L

          -  Platelet count ≥ 100,000/μL

          -  No evidence of second or third degree atrioventricular block

          -  No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration,
             SVT > 4 beats/minute)

          -  QRS interval ≤ 110 ms

          -  QTcF interval of < 450 ms

          -  PR interval ≤ 200 ms

          -  Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared
             slides)

        Key Exclusion Criteria:

          -  Another known activating oncogene driver mutation

          -  Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors

          -  Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2
             antibody drug conjugates

          -  Investigational therapy administered within the 28 days or 5 half lives

          -  Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1

          -  Immunotherapy within 21 days

          -  Clinically active or symptomatic interstitial lung disease (ILD) or interstitial
             pneumonitis, or a history of clinically significant ILD or radiation pneumonitis

          -  Untreated and/or symptomatic CNS malignancies (primary or metastatic);

          -  Receiving medication that prolongs QT interval, with a risk of causing Torsade de
             Pointes (TdP)

          -  Personal or familial history of Long QT Syndrome

          -  NYHA class III or IV or LVEF < 55%

          -  Myocardial infarction, severe or unstable angina within 6 months

          -  History of TdP, ventricular arrhythmia

          -  Significant thrombotic or embolic events within 3 months

          -  Uncontrolled or severe cardiovascular disease

          -  Concurrent malignancy expected to require treatment within 2 years or interfere with
             study outcomes

          -  History of severe allergic reactions or hypersensitivity to compounds of similar
             chemical or biologic composition as tarloxotinib

          -  Known HIV infection or active Hepatitis B or C
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR
Time Frame:through study completion, an average of 10 months
Safety Issue:
Description:Objective Response Rate (number of subjects with PR or CR)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Rain Therapeutics Inc.

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