Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision (no safety or efficacy concerns)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antidiarrheal prophylaxis | Drug | — | UNRESOLVED |
| TAK-788 | Drug | TAK-788 | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- TAK-788 160 mg, capsules, orally, once daily (QD) with or without a low-fat meal until disease progression or as assessed by the investigator during every 3-week cycle.
- interventionNames
- Drug: TAK-788
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- TAK-788 160 mg, capsules, orally, QD with or without a low-fat meal and antidiarrheal prophylaxis administered during the first 8 weeks of treatment until disease progression or as assessed by the investigator during every 3-week cycle.
- interventionNames
- Drug: TAK-788
- Drug: Antidiarrheal prophylaxis
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with histologically or cytologically confirmed nonsquamous cell locally advanced (not suitable for definitive therapy) or metastatic non-small-cell lung cancer (NSCLC) (Stage IIIB or IV) NSCLC; and, has received at least 1 prior line of therapy for this disease. 2. A documented epidermal growth factor receptor (EGFR) mutation with in-frame exon 20 insertion, confirmed as follows: * For sites located in the United States (US): assessment must be done by a certified laboratory functioning under the guidelines of the Clinical Laboratory Improvements Amendment (CLIA). * For site located outside of the US: assessment must be done by an accredited local laboratory. Note: A documented EGFR in-frame exon 20 insertion or insertion-duplication includes but is not limited to one of the following: * A763\_Y764insFQEA, * V769\_D770insASV (also referred to as ASV duplication) * D770\_N771insNPG * D770\_N771insSVD (also referred to as SVD duplication) * H773\_V774insNPH (also referred to as NPH duplication), or * Any other in-frame insertion mutation in the exon 20 \[amino acids 739 -823\]. The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations. The reported insertion-duplication can have been detected on either tissue or liquid biopsy using a well-validated test based on either polymerase chain reaction, sequencing or next-generation sequencing (NGS). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Minimum life expectancy of ≥3 months. 5. All toxicities from prior therapy have been resolved to ≤Grade 1, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or have resolved to baseline, at the time of first dose of TAK-788. Exclusion Criteria: 1. Has been diagnosed with another primary malignancy other than NSCLC, except for the following: 1. Adequately treated non-melanoma skin cancer or cervical cancer in situ. 2. Definitively treated non-metastatic prostate cancer. 3. Non-NSCLC primary malignancies that are definitively relapse-free for ≥3 years. 2. Has unstable brain metastases to include previously untreated intracranial central nervous system (CNS) metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions. \- Brain metastases that are stable do not preclude eligibility if they have been treated with surgery and/or radiation, and have been stable without requiring corticosteroids to control symptoms within 7 days before randomization, and have no evidence of new or enlarging brain metastases. 3. Has a current spinal cord compression (symptomatic or asymptomatic that is detectable by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic). 4. Currently has or has had a history of interstitial lung disease, to include radiation or drug related pneumonitis that requires/required steroid treatment. 5. Has an ongoing or active infection, to include but not limited to infections requiring intravenous antibiotics or has a known history of HIV. Testing for HIV is not required in the absence of history. Note: Hepatitis B surface antigen-positive participants are allowed to enroll if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is below 1000 copies/mL in the plasma. Patients who are positive for anti-hepatitis C virus antibody can be enrolled but must not have detectable hepatitis C virus (HCV) RNA in the plasma. 6. Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure. 7. A prolonged QTcF interval, or is being treated with medications known to be associated with the development of Torsades de Pointes. 8. Has a GI illness or disorder, including but not limited to a history of GI perforation, that could affect oral absorption of TAK-788.
References
Publications (0)
Data not yet available