drugset / Trial / NCT04576208

A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788

NCT04576208

Phase 2 Withdrawn Takeda
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations treated with TAK-788 when administered with or without intensive loperamide prophylaxis.

Timeline

Start
2020-11-30
Primary completion
2022-07-31
Completion
2022-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Loperamide Small molecule
Subject Mobocertinib Small molecule 160 mg Oral