Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Evixapodlin: 500 mg dose - one 500 mg tablet QD
Control Intervention1: Evixapodlin: 1000 mg dose - two 500 mg tablets QD
Sponsors
OmRx Oncology, Inc.
KlinEra Global Services
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years of age, inclusive at the time of signing informed consent form (ICF). 2. Voluntarily agreed to participate in this study by providing a signed, dated and ethics committee (EC) approved ICF before any protocol directed screening procedures are performed. 3. Capable of understanding and complying with protocol requirements, including daily compliance with administration of investigational medication, ability to travel to study visits and radiology appointments (in the opinion of the Investigator) 4. Regionally advanced, unresectable, histologically or cytologically documented, Stage IIIB or Stage IV NSCLC, who have recurrence or progression during or after one prior platinum containing chemotherapy regimen for advanced or metastatic disease. 5. At least one measurable non central nervous system NSCLC lesion qualifying as measurable disease per RECIST based on assessment by central radiologist 6. Tumor PD L1 high expression with one of the prespecified commercial IHC assays above the defined threshold. 7. Subjects must agree to provide a fresh biopsy sample or sufficient archival tumor tissue for Screening Period testing if (1) PD L1 expression or (2) AGA results for ALK or ROS rearrangement, EGFR mutations, are not available in the participants medical record. 8. At least 28 days must have elapsed since the last thoracic surgery and subjects should have recovered from all associated toxicities by the time of the first planned dose of study medication (Baseline C1D1). 9. The last dose of prior, systemic, anti cancer therapy must have been administered grater than or equal to 21 days prior to Baseline (C1D1), with the exception being TKIs approved for treatment of NSCLC have to be discontinued greater than or equal to 7 days prior to Baseline (C1D1). 10. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at Screening and pre dose at Baseline, prior to the first dose of study medication. 11. Life expectancy greater or equal to 3 months, as assessed by Investigator (at Screening and at Baseline prior to first dose of study medication). 12. Negative serum pregnancy test for female subjects who are of childbearing potential within 14 days prior to the first dose of study drug at Baseline or be of non childbearing potential defined as postmenopausal or be surgically sterile (as documented in the medical record). 13. Female subjects of childbearing potential must agree to use protocol specified method(s) of contraception. 14. Females who are nursing must agree to permanently discontinue nursing (breastfeeding) before the first dose of evixapodlin. 15. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study, for 90 days following the last dose of study, and must agree to use protocol specified method(s) of contraception. 16. Subjects must have body weight 30 kg and may not present with severe weight loss (greater than 10 percent) within 6 weeks prior to randomization at Baseline Visit (based on subject self report and Investigator judgment).
Exclusion criteria
Exclusion criteria: 1. NSCLC diagnosis with positive AGA for ALK or ROS rearrangement, or EGFR mutations. 2. Known history of an additional malignancy likely to interfere with NSCLC treatment. 3. Toxicity from prior therapy without demonstrating sufficient recovery. 4. Prior treatment with immune modulators, including prior treatment with evixapodlin or another investigational oral checkpoint inhibitor. 5. Central nervous system (CNS) metastases that are symptomatic or require treatment and/or carcinomatous meningitis (i.e., leptomeningeal metastasis). 6. Received thoracic radiation within 3 months of Baseline (the first planned dose of study medication (C1D1)) and any concurrent or planned palliative radiotherapy. 7. Pregnant 8. Participation in another interventional clinical study while receiving evixapodlin. 9. Major medical conditions that might affect study participation (e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled serious infection). 10. Impaired cardiac function, or clinically significant cardiac disease, or clinically important abnormalities in conduction or morphology of resting ECG at Screening, including: a. Unstable angina b. Myocardial infarction within 6 months prior to screening c. New York Heart Association Class II or greater congestive heart failure d. Uncontrolled hypertension e. Poorly controlled arrhythmias within the last 6 months of first dose of study drug f. Clinically important abnormalities in conduction defined as corrected QT interval by Fridericia method (QTcF) >=450 msec in men, >=470 msec in women. 11. History or evidence of interstitial lung disease including noninfectious pneumonitis, hypersensitivity pneumonitis OR a history of pneumonitis that required oral or IV steroids OR pulmonary conditions such as clinically significant sarcoidosis, silicosis, or idiopathic pulmonary fibrosis. 12. Symptomatic pleural effusion. 13. Stroke or transient ischemic attack or seizure disorder within 6 months prior to Screening. 14. Gastrointestinal (GI) or bowel conditions, surgery or symptoms that may affect drug absorption, a. GI surgery within 6 weeks of Screening b. GI symptoms of nausea, diarrhoea, or vomiting greater than CTCAE Grade 1 at time of Screening or at first dose of study drug or that in the opinion of the Investigator will interfere with study participation. c. Risk factors for bowel obstruction or bowel perforation (e.g., acute diverticulitis) d. Abdominal carcinomatosis 15. Active autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Bells palsy, Guillain Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. 16. Subjects with a diagnosis of endocrine deficiencies who have not been stabilized on replacement therapy (e.g., thyroid replacement) prior to Screening 17. Subjects with Type 1 diabetes mellitus, or Type 2 diabetes mellitus with HbA1c >=9% at Screening 18. Inability to discontinue sulfonylureas (e.g., glipizide, glyburide), be safely switched to another hypoglycemic agent (e.g. sitagliptin or another DPP4 inhibitor) and be on stable dose for at least 14 days before Baseline (C1D1) 19. Receipt of chronic s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the overall response rate (ORR) to evixapodlin in NSCLCTimepoint: Week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the disease control rate (DCR) to evixapodlin in NSCLCTimepoint: Week 6;To determine overall survival (OS) and radiographic progression free survival (rPFS)Timepoint: Week 96;To determine the safety of evixapodlin in advanced NSCLCTimepoint: Week 96;To characterize the pharmacokinetic (PK) profile of evixapodlin in subjects with NSCLCTimepoint: Baseline, Week 2, Week 8 and Week 16;To evaluate the change in circulating tumor DNA (ctDNA) over timeTimepoint: Baseline and Week 8 | — |
Countries
India, New Zealand
Contacts
Public ContactGaurav Kadam
KlinEra Global Services
Outcome results
None listed