A study evaluating novel BRAF inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic BRAF V600 mutant non-small cell lung carcinoma.
- Conditions
- on-small cell lung cancerMedDRA version: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005014-34-IT
- Lead Sponsor
- OVARTIS FARMA S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 58
- Male or female patients, age = 18 years
- Presence of BRAF V600E mutation in tumor tissue prior to study treatment, as determined by the specified investigational diagnostic test at a Novartis designated central laboratory
- Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- At least one measurable lesion as defined by RECIST v1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
- Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
•Prior cytotoxic chemotherapy must include a platinum doublet.
•(Neo-)adjuvant cytotoxic chemotherapy counts as one prior line of treatment if relapse occurred within 12 months from the end of the (neo-)adjuvant cytotoxic chemotherapy.
- ECOG/World Health Organization (WHO) performance status 0-2
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39
- Patients with symptomatic CNS metastases (neurologically unstable or required increasing doses of steroids within the 2 weeks prior to study entry)
- History of leptomeningeal metastases (carcinomatous meningitis)
- Prior therapy with a BRAF inhibitor
- Patients who have received thoracic radiotherapy to lung fields = 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy = 2 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions = 2 weeks prior to starting study treatment is allowed
- Patients taking non-topical medication known to be a strong inhibitor of CYP3A4.However patients who either discontinue their treatment or switch to another medication at least three days prior to the first administration of LGX818 are eligible.
- Patients who underwent major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting study drug or who have not recovered from side effects of such procedures. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery, and patients can be enrolled in the study = 1 week after the procedure
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Uncontrolled arterial hypertension despite medical treatment
- Patient is receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-CNS), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method