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

A Randomized Open-label Phase 2 Multicenter Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Receiving TAK-788

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called TAK-788. TAK-788 administered with or without antidiarrheal prophylaxis is being tested to evaluate the impact of management strategies on gastrointestinal-related adverse events in participants with non-small cell lung cancer harboring EGFR Exon 20 insertion mutations receiving TAK-788. The study will enroll approximately 90 patients. Participants will be randomly assigned in 1:1 ratio (by chance, like flipping a coin) to one of the two treatment groups- * Cohort 1 * Cohort 2 All participants will be asked to take TAK-788 capsules with or without a low-fat meal in Cohort 1 and TAK-788 capsule with antidiarrheal prophylaxis and with or without a low-fat meal in Cohort 2. This is a multi-center trial and will be conducted worldwide. The overall time to participate in this study is approximately 2 years. Participants will make multiple visits to the clinic after receiving their last dose of drug for a follow-up assessment.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	TAK-788	TAK-788 capsules
DRUG	Antidiarrheal prophylaxis	Antidiarrheal prophylaxis includes loperamide tablet administered as per routine clinical practice.

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2020-10-06
• Last updated: 2020-12-17

Regulatory

• FDA-regulated drug study