A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Squamous Non Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Necitumumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01769391

I4X-MC-JFCL (Other Identifier)

2012-003214-13 (EudraCT Number)

14790

Details and patient eligibility

About

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed squamous NSCLC
• Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
• Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
• Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments

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 NSCLC
• Major surgery or received any investigational therapy in the 4 weeks prior to randomization
• Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
• Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Necitumumab +Paclitaxel+Carboplatin

Experimental group

Description:

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Necitumumab

Paclitaxel + Carboplatin

Active Comparator group

Description:

Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin