SHS_492249 WESH CCLG 14014

A phase III, randomized, open-label, crossover, multi-center, safety and efficacy study to evaluate nab-Paclitaxel (Abraxane) as maintenance treatment after induction with nab-Paclitaxel plus carboplatin in subjects with squamous cell non-small cell lung cancer (NSCLC)

Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or SD with nab-paclitaxel plus carboplatin as induction in subjects with stage IIB/IV squamous cell NSCLC.

Inclusion Criteria:

Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
No other current active malignancy requiring anticancer therapy.
Radiographically documented measurable disease at study entry (as defined by the RECIST v1.1 criteria).
No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.

Exclusion Criteria:

Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to first dose of study drug).
Only evidence of disease is non measurable at study entry.
Preexisting peripheral neuropathy of Grade 2, 3, or 4.
Venous thromboembolism within 6 months prior to signing Informed Consent Form.
Current congestive heart failure (New York Heart Association class II-IV).
History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
Subject has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) — all treatments that should have been completed 6 months prior to signing ICF.
Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting IP, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
Phase III
Cancer, All Other
Howard (Jack) West, M.D.
Celgene Corporation
Andrew Smith
  • Swedish Medical Center