Loading clinical trials...

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

WITHDRAWNPHASE2

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

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)

NCT02941601•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.
+2 more criteria

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.

Locations (19)

Fairview Southdale Oncology Clinic

Edina, Minnesota, United States

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.

Haine-St.- Paul, Belgium

Liège, Belgium

Roeselare, Belgium

Bamberg, Germany

Hanover, Germany

Kassel, Germany

Avellino, Italy

Messina, Italy

Naples, Italy

Key Dates

Start Date

November 1, 2016

Primary Completion Date

December 1, 2017

Completion Date

February 1, 2019

Last Updated

September 27, 2019

Conditions

Locally Advanced Squamous Non-Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung Cancer

Interventions

Necitumumab

DRUG

Gemcitabine

DRUG

Carboplatin

DRUG