NSCLC Exon 20 or HER2-activating Mutations

Non Small Cell Lung Cancer Clinical Trial

— RAIN  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03743350
• Other study ID #: RAIN-701
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2019
• Est. completion date: January 2021

Study information

• Verified date: November 2018
• Source: Rain Therapeutics, inc
• Contact: Thomas M Tremblay, RN BSN
• Phone: (510) 250-3705
• Email: ttremblay[@]rainthera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2, Open Label, single treatment

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation Exon 20
• HER2 Gene Mutation
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Tarloxotinib
Intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rain Therapeutics, inc

Outcome

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