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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loperamide | Small molecule | — | — |
| Subject | Mobocertinib | Small molecule | 160 mg | Oral |