Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allist Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years at time of signing Informed Consent Form
Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
Measurable disease per RECIST v1.1
ECOG performance status of 0 or 1
Life expectancy of ≥ 12 weeks
Patients with CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside the CNS; No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment; No ongoing symptoms attributed to CNS metastases; No active CNS metastases or spinal cord compression (i.e., progressing or requiring anticonvulsants or corticosteroids for symptomatic control); No evidence of interim CNS disease progression between the completion of CNS-directed therapy and the screening radiographic study; Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
For women of childbearing potential or men who are not surgically sterile: Agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs or sperm
You may not be if
Prior treatment with any EGFR-targeting agents (e.g., EGFR tyrosine kinase inhibitors \[TKIs\], monoclonal antibodies, or bispecific antibodies).
More than 3 prior systemic anticancer therapy regimens for locally advanced or metastatic NSCLC
Inability or unwillingness to swallow pills
Severe acute or chronic infections
Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected ILD
History of or active clinically significant cardiovascular dysfunction
Mean resting corrected QT interval (QTc) \> 470 msec, obtained from triplicate ECGs, using the screening clinic ECG machine derived Fridericia's formula (QTcF) value
Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval (e.g., complete left bundle branch block, degree III atrioventricular block, second-degree heart block, PR interval \> 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, serious hypokalemia, heart failure) or current use of the drugs that may lead to prolonged QT interval.
AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, endocrinopathy managed with replacement therapy, or Grade ≤ 2 peripheral neuropathy.
