Randomized, Double-Blind, Multicenter, Study Comparing an Active Drug Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

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

Squamous Non-Small Cell Lung Cancer
970 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Eligibility criteria

Participant attributes:
Male and Female


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.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 1Z2
Hamilton - L8V 1C3
London - N6A 4L6
Ottawa - K1H 8L6
Toronto - M5G 2M9
Montreal - H3G 1A4
Quebec City - G6V 3Z1
Québec - G1V 4G5
Quebec City - G6V 3Z1

More information about this study