NSCLC Exon 20 or HER2-activating Mutations

• Status: Not yet recruiting
• Trial end date: 2021-01-01
• Target enrollment: 40
• Participant gender: All

Summary

Phase 2, Open Label, single treatment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rain Therapeutics, inc

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