A Study of nab®-Paclitaxel (Abraxane®) and Carboplatin plus Necitumumab (LY3012211) in Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 1

• Conditions: Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC); MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002071-96-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-19
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Key Inclusion Criteria
- Histologically or cytologically confirmed squamous NSCLC
- Stage IV disease at the time of study entry (AJCC Staging Manual, 7th edition)
- Measurable disease at the time of study enrollment, as defined by RECIST 1.1
- Tumor tissue (paraffin-embedded tissue block [preferred] or 15 freshly cut unstained slides [a minimum of 6 slides] is requested) available for analysis of EGFR protein expression by immunohistochemistry (IHC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

Key Exclusion Criteria
- Nonsquamous NSCLC
- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- Previous chemotherapy for advanced NSCLC
- Major surgery or received any investigational therapy in the 4 weeks prior to study entry
- Systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry
- Symptomatic central nervous system (CNS) malignancy or metastasis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified