Clinical Trials/NCT02941601

NCT02941601

Withdrawn

Phase 2

A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company2 sites in 2 countriesNovember 2016

ConditionsLocally Advanced Squamous Non-Small Cell Lung Cancer Metastatic Squamous Non-Small Cell Lung Cancer

InterventionsGemcitabine Necitumumab Carboplatin

DrugsNecitumumab Gemcitabine Carboplatin

Overview

Phase: Phase 2
Intervention: Gemcitabine
Conditions: Locally Advanced Squamous Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Locations: 2
Primary Endpoint: Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

February 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Arms & Interventions

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Intervention: Gemcitabine

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Intervention: Necitumumab

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Intervention: Gemcitabine

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Intervention: Carboplatin

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Intervention: Necitumumab

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Intervention: Carboplatin

Outcomes

Primary Outcomes

Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response

Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months)

Secondary Outcomes

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))