NCT02264990

Study Comparing an Active Drug Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

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

Status:
Completed
Conditions:
Non-squamous Non-small Cell Lung Cancer
Enrollment:
595 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-359
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

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.

All the cities where the clinical studies are located

Halifax - B3H 1V7
London - N6A 4L6
Windsor - N9C 3Z4
Quebec City - G6V 3Z1
Quebec City - G6V 3Z1

Nova Scotia

Quebec

More information about this study

clinicaltrials.gov