A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company247 enrolled

Overview

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

247

Conditions

Non-Small-Cell Lung Cancer

Interventions

pemetrexedDRUG

500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops

erlotinibDRUG

150 mg, orally, once daily until progression or unacceptable toxicity develops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer * Patients must be non-smokers * Patients must have at least one measurable lesion * Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale * Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease. Exclusion Criteria: * Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Patients who have previously received treatment with drugs against the human epidermal growth factor receptors * Patients who have previously received treatment with drugs which have similar targets as Pemetrexed * Patients who have any known significant ophthalmologic abnormalities of the surface of the eye * Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

Locations (29)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.

Time frame: Randomization to measured PD up to 38 months

Secondary Outcomes

Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]

TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.

Time frame: Randomization to measured disease progression up to 38 months

Overall Survival (OS)

OS is defined as the time from randomization to the date of death from any cause.

Time frame: Baseline to date of death from any cause up to 45.5 months

Number of Participants With Adverse Events

A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.

Time frame: Randomization up to 39 months

Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)

Data from ClinicalTrials.gov

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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.

Barretos, Brazil

Ijuí, Brazil

São Paulo, Brazil

Beijing, China

Nanning, China

Shanghai, China

Shatin, Hong Kong

Ahmedabad, India

Bhopal, India

Hyderabaad, India

...and 19 more locations

Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)

TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).

Time frame: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months