Clinical Trials /

NSCLC Exon 20 or HER2-activating Mutations

NCT03743350

Description:

Phase 2, Open Label, single treatment

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

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03743350

Trial Eligibility

Document

Title

  • Brief Title: NSCLC Exon 20 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: NCT03743350

Conditions

  • Non Small Cell Lung Cancer
  • EGFR Gene Mutation Exon 20
  • HER2 Gene Mutation

Interventions

DrugSynonymsArms
TarloxotinibTarloxActive

Purpose

Phase 2, Open Label, single treatment

Detailed Description

      Phase 2 multicenter, open label study to evaluate the antitumor effect of tarloxotinib in 2
      cohorts of patients with previously treated advanced/metastatic NSCLC and whose tumor harbors
      either an EGFR exon 20 insertion or a HER2 activating mutation (including HER2 exon 20
      insertions).

Trial Arms

NameTypeDescriptionInterventions
ActiveExperimentalTarloxotinib IV Infusion
  • Tarloxotinib

Eligibility Criteria

        Inclusion Criteria:

          -  NSCLC, Stage IV, Stage IIIB or III C not amenable to definitive curative intent
             therapy, or recurrent disease after prior diagnosis of Stage I III disease

          -  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

          -  Adequate organ function

        Exclusion Criteria:

          -  Another known oncogene driver mutation

          -  Previous treatment with anti-EGFR or anti-HER2 tyrosine kinase inhibitors

          -  Previous treatment with anti-EGFR or anti-HER2 monoclonal antibodies or antibody drug
             conjugates

          -  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

          -  medication that prolongs QT interval

          -  risk of Long QT Syndrome

          -  significant cardiovascular disease

          -  known human HIV infection or active hepatitis B or C

          -  pregnancy
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate RECIST 1.1
Time Frame:through study completion, an average of 12 months
Safety Issue:
Description:PR or CR with confirmation

Secondary Outcome Measures

Measure:Duration of response
Time Frame:through study completion, an average of 12 months
Safety Issue:
Description:time from date of first response

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Rain Therapeutics, inc

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