NCT02264990
Brief summary
This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of an active drug plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell lung cancer.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Subject must be ≥ 18 years of age with life expectancy > 12 weeks.
- Subject must have cytologically or histologically confirmed advanced or metastatic
non-squamous NSCLC and are current or former smokers.
- Subject must have NSCLC that is not amenable to surgical resection or radiation with
curative intent at time of screening.
- Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed
tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1.
Exclusion Criteria:
- Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).
- Subject has a known hypersensitivity to platinum compounds.
- Subject has peripheral neuropathy ≥ grade 2.
- Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor
(EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known
anaplastic lymphoma kinase (ALK) gene rearrangement.
- Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
