A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Withdrawn

• Conditions: Locally Advanced Squamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: Necitumumab; Drug: Gemcitabine; Drug: Carboplatin

• Registration Number: NCT02941601
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Study Start: 2016-11
• Primary Completion: 2017-12
• Study Completion: 2019-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
• Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.
• Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
• The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
• Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)
• The participant has archived tumor tissue available for biomarker analyses.
• Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.

Exclusion Criteria

• The participant has nonsquamous NSCLC
• The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
• The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).
• The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
• The participant has a bleeding tumor.
• The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.
• The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.
• The participant has experienced myocardial infarction within 6 months prior to study enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1: Necitumumab + Gemcitabine and Carboplatin	Gemcitabine	Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
Cohort 1: Necitumumab + Gemcitabine and Carboplatin	Carboplatin	Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
Cohort 2: Necitumumab + Gemcitabine and Carboplatin	Gemcitabine	Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
Cohort 2: Necitumumab + Gemcitabine and Carboplatin	Necitumumab	Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
Cohort 1: Necitumumab + Gemcitabine and Carboplatin	Necitumumab	Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
Cohort 2: Necitumumab + Gemcitabine and Carboplatin	Carboplatin	Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response	Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Baseline to Date of Death Due to Any Cause (Approximately 24 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab	Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months)
Progression Free Survival (PFS)	Baseline to Measured Progressive Disease or Death (Approximately 24 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease	Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months)

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 London, United Kingdom

Fairview Southdale Oncology Clinic; 🇺🇸 Edina, Minnesota, United States