CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Afatinib +2 moredrug
Likely dose
Afatinib 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02795156
NCT02795156Phase 2Completed

Phase II Study to Evaluate the Activity of Commercially Available Molecularly Matched Targeted Therapies in Selected Tumor Types Based on Genomic Alterations

SCRI Development Innovations, LLC·interventional·Posted Jun 9, 2016·Updated Dec 5, 2023

In Brief

A Phase 2 clinical trial evaluating Afatinib, Regorafenib, and 1 other intervention for Non-small Cell Lung Carcinoma and 3 related conditions. Completed, enrolled 100 participants across 8 sites.

Detailed Summary

With the increased availability of next-generation sequencing, oncologists are starting to incorporate genomic profiling into routine care of cancer patients. If a genomic alteration is identified during profiling, it could help guide the choice of therapy and improve treatment outcomes. This study will examine the anti-tumor activity of selected commercially available molecularly matched targeted therapies in patients who have failed first-line treatment for one of the following tumor types: non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and upper aerodigestive tract cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2016
Enrollment StartSep 28, 2016
Primary CompletionAug 17, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 10.1 years ago

Interventions

Afatinibdrug

40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.

Regorafenibdrug

160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.

Cabozantinibdrug

60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.