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

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. Identifier: NCT03805841
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : April 3, 2019
Information provided by (Responsible Party):
Rain Therapeutics Inc.

Brief Summary:
Open-label, Phase 2, single treatment arm, 2 cohorts

Condition or disease Intervention/treatment Phase
NSCLC, Stage IV NSCLC Stage IIIB NSCLC, Stage IIIC NSCLC, Recurrent EGFR Exon 20 Insertion Mutation HER2-activating Mutation Drug: tarloxotinib bromide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active
tarloxotinib bromide
Drug: tarloxotinib bromide
weekly intravenous infusion
Other Names:
  • Tarlox
  • tarloxotinib

Primary Outcome Measures :
  1. ORR [ Time Frame: through study completion, an average of 10 months ]
    Objective Response Rate (number of subjects with PR or CR)

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT03805841

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Contact: Thomas Tremblay, RN BSN +1 (510) 250-3705

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United States, California
Potential RAIN-701 Study Site Recruiting
Irvine, California, United States, 92697
Contact: Kim Inocencio   
United States, Colorado
Potential RAIN-701 Study Site Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Tremblay    510-250-3705   
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Tisdrey Torres, BSN, RN    202-687-9861   
United States, Pennsylvania
Potential RAIN-701 Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Thomas Tremblay    510-250-3705   
United States, Washington
Potential RAIN-701 Study Site Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Thomas Tremblay    510-250-3705   
Canada, Ontario
Potential RAIN-701 Study Site Not yet recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Thomas Tremblay    +1 510-250-3705   
Hong Kong
Potential RAIN-701 Study Site Not yet recruiting
Hong Kong, Hong Kong
Contact: Thomas Tremblay    +1 510-250-3705   
Sponsors and Collaborators
Rain Therapeutics Inc.
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Principal Investigator: Stephen V Liu, MD Georgetown University

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Responsible Party: Rain Therapeutics Inc. Identifier: NCT03805841     History of Changes
Other Study ID Numbers: RAIN-701
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Lung Diseases
Respiratory Tract Diseases