Non Small Cell Lung Cancer Clinical Trial
— RAINOfficial 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
Phase 2, Open Label, single treatment
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rain Therapeutics, inc |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate RECIST 1.1 | PR or CR with confirmation | through study completion, an average of 12 months | |
Primary | Adverse Events | Adverse Events | through study completion, an average of 12 months | |
Secondary | Duration of response | time from date of first response | through study completion, an average of 12 months |
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