Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: LNP3794, 8 mg (4 capsules each of 2 mg), once daily, per oral till end of treatment / early discontinuation: Inhibitor of MEK Kinase
Control Intervention1: Not Applicable: Not Applicabl
Sponsors
Lupin Limited Research Park
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender (>= 18 years) with locally advanced or metastatic NSCLC that has progressed after standard treatment, which must have included chemotherapy and/or targeted therapy and/or immunotherapy. 2. Patients with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic (Stage IIIB to Stage IV) NSCLC 3. Patients with or without known RAS mutational status Or those willing to send tissue/blood sample for RAS testing 4. Patients with measurable disease, i.e., presenting with at least one measurable tumor lesion as per the RECIST v1.1 5. Patients with an ECOG performance status score of 6. Patients must be able to swallow orally administered medication 7. Patients having adequate liver and renal function and without clinically significant laboratory abnormalities in the opinion of the investigator 8. Patients must have adequate life expectancy in the opinion of the Investigator 9. Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v 4.03) 10. Women of childbearing potential must have a negative serum pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry through at least 1 month after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) 11. A female patient of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle-stimulating hormone level > 40 mIU/mL at Screening, or have had surgical bilateral oophorectomy, hysterectomy, or tubal ligation > 6 weeks prior to Screening; in the case of oophorectomy alone, reproductive status will be confirmed by hormone level assessment 12. A male patient must agree to use adequate contraception from study entry through at least 1 month after the last dose of study medication 13. Patients must be willing to undergo and able to tolerate frequent magnetic resonance imaging (MRI) or computed tomography (CT) assessments during the study 14. Patients must be able to understand and be willing to provide voluntary signed and dated written informed consent 15. Patients willing and able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with symptoms of central nervous system metastases 2. Patients with a history of another primary malignancy, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of the uterine cervix. A patient who has had no evidence of disease from another primary cancer for 5 or more years is allowed to participate in the study 3. Patients with any serious and/or unstable pre-existing medical disorder aside from malignancy exception above, psychiatric disorder, seizure disorder, or other conditions that could interfere with the patientâ??s safety, providing informed consent or compliance to the study procedures, in the opinion of the Investigator 4. Patients with a history of treatment failure with other MEK inhibitors such as selumetinib, trametinib 5. Chemotherapy and radiation therapy within the last 3 weeks prior to enrollment or limited field of radiation for palliation within 7 days of the first dose of study medication 6. Patients who have a history or current evidence/risk of retinal vein occlusion or central serous retinopathy; for example, predisposing factors of RVO or central serous retinopathy include uncontrolled glaucoma or ocular hypertension, history of hyper viscosity or hypercoagulability syndromes 7. Patients who have liver disease such as cirrhosis, de-compensated liver disease, chronic active hepatitis, or chronic persistent hepatitis 8. Patients with impaired cardiac function or clinically significant cardiac diseases, in the opinion of the Investigator including any of the following: a. Concomitant medications or diseases that could prolong the QT interval or affect the cardiac conduction system, as assessed by the Investigator, such as autonomic neuropathy caused by diabetes or Parkinsonâ??s disease, cirrhosis, uncontrolled hypothyroidism, or cardiac failure b. Any of the following within 3 months prior to the first dose of study medication: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure New York Heart association Class III or IV, cerebrovascular accident, or transient ischemic attack c. Clinically significant heart disease such as uncontrolled hypertension refer to World Health Organization International Society of Hypertension guidelines 9. Patients positive for human immunodeficiency virus infection, hepatitis C or chronic active hepatitis B 10. Biologic therapy, targeted therapy, immunotherapy or other investigational agents within 5 half lives or within 3 weeks whichever is earlier prior to the first dose of the study medication; or the patients who, in the opinion of the Investigator, have not recovered from the side effects of these therapies within the 1 week prior to the first dose of study medication 11. Major surgery or surgical therapy for any cause within 4 weeks of Screening or those who in the Investigator opinion, likely require major surgery during the study 12. Women who are pregnant, lactating, or planning pregnancy during the study 13. Patients requiring drugs that are prohibited in the concomitant medication section 14. Patients participating concurrently in any other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR: Disease Control Rate is defined as the proportion of patients who achieve Complete Response (CR) or Partial Response (PR) or stable disease (SD) according to RECIST v1.1 at 12 weeksTimepoint: at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (AE) and serious adverse events (SAE) 2. DCR: Disease Control Rate during the treatment period 3. ORR: Objective Response Rate according to RECIST v1.1. 4. BOR: Best Overall Response according to RECIST v1.1 5. PFS: Progression Free Survival (PFS) 6.Overall Survival (OS) will be measured as the time (in months) between the start of the study treatment and the date of deathTimepoint: During 12 weeks | — |
Countries
India
Contacts
Public ContactDr Amit Joshi
Lupin Limited (Research Park)
Outcome results
None listed