Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT04535557
Eligibility Criteria:
Inclusion Criteria:
1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC
2. Have a documented EGFR in-frame exon 20 insertion mutations
3. . Must have received at least 1 prior line of therapy for locally advanced or metastatic disease
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
5. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected Fridericia (QTcF) of less than or equal to (\<=) 450 milliseconds (ms) in males or \<=470 ms in females
Exclusion Criteria:
1. Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) \<=14 days prior to first dose of mobocertinib (except for reversible EGFR tyrosine kinase inhibitors (TKIs) \[that is, erlotinib or gefitinib\], which are allowed up to 7 days prior to the first dose of mobocertinib)
2. Received radiotherapy \<=14 days prior to the first dose of mobocertinib or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose
3. Have known active brain metastases. Brain metastases are allowed if they have been treated with surgery and/or radiation
4. Have current spinal cord compression or leptomeningeal disease
5. Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:
* Myocardial infarction (MI);
* Unstable angina;
* Congestive heart failure (CHF);
* Clinically significant arrhythmia;
* Ventricular arrhythmia; or
* Cerebrovascular accident;
* Transient ischemic attack.
* Cardiac ejection fraction less than (\<) 50 percent (%) by echocardiogram or multigated acquisition (MUGA) scan.
6. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes
7. Have presence of diarrhea that can be related to anti-tumoral treatment (including EGFR TKI, immune therapy, chemotherapy, and investigational therapies)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04535557
Study Brief:
Protocol Section:
NCT04535557