NCT02106546
Brief summary
This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of an active drug plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in subjects with advanced or metastatic squamous NSCLC.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 99 Years.
Inclusion Criteria:
1. Life expectancy > 12 weeks
2. Subject must have cytologically or histologically confirmed squamous NSCLC.
3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to
surgical resection or radiation with curative intent at time of study Screening.
4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable
to surgical resection or radiation with curative intent are eligible.
5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized
tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors
(RECIST - version 1.1).
Exclusion Criteria:
1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).
2. Subject has a known hypersensitivity to platinum compounds.
3. Subject has peripheral neuropathy >= grade 2.
4. Subject has non-squamous NSCLC, or a 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.
5. Subject has received prior cytotoxic chemotherapy (including definitive
chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
