A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

Eli Lilly and Company61 enrolled

Overview

The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

NecitumumabDRUG

Administered IV

GemcitabineDRUG

Administered IV

CisplatinDRUG

Administered IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC) * Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition * Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 * Required to have a performance status (PS) 0-1 Exclusion Criteria: * Nonsquamous NSCLC * Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (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 study enrollment * 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)

Locations (17)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.

Time frame: Baseline to Measured Progressive Disease (up to 17 Months)

Secondary Outcomes

Overall Survival (OS)

Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.

Time frame: Baseline to Death from Any Cause (up to 17 Months)

Progression Free Survival (PFS)

PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.

Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

Deerfield Beach, Florida, United States

Farmington Hills, Michigan, United States

Calgary, Alberta, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Montreal, Quebec, Canada

Paris, France

Durango, Mexico

Guadalajara, Mexico

...and 7 more locations