Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Stage IIIB or IV NSCLC (any histology) at the time of study entry
Histologically or cytologically confirmed diagnosis of NSCLC that is:
1. EGFR wt as per patient standard of care by a validated test
2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
3. AND (by central assessment) either:
* Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
* Cohort 2: Pre-treated patients with cMET GCN ≥4 and \< 6, or
* Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
At least one measurable lesion as defined by RECIST 1.1
Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
Patients must have adequate organ function
ECOG performance status (PS) of 0 or 1
You may not be if
Prior treatment with crizotinib, or any other cMET or HGF inhibitor
Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
Patients with characterized ALK-positive rearrangement
Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
* Strong and moderate inhibitors of CYP3A4
* Strong inducers of CYP3A4
Impairment of GI function or GI disease that may significantly alter the absorption of INC280
Patients receiving treatment with any enzyme-inducing anticonvulsant
Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
Pregnant or nursing women
Women of child-bearing potential, unless they are using highly effective methods of contraception
Sexually active males unless they use a condom during intercourse
Clareo Health | Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)
