QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; NantCell, Inc.
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced squamous NSCLC

• Measurable disease as defined per modified RECIST criteria

• ECOG performance status of 0 or 1

• ≥18 years old

• Adequate glycemic function, for subjects with known diabetes

Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases

• Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC