A Phase II Study of Pemetrexed and Cisplatin plus Cetuximab followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) other than Predominantly Squamous Cell Histology - S104

• Conditions: ocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) other than Predominantly Squamous Cell Histology; MedDRA version: 9.1Level: LLTClassification code 10025055; MedDRA version: 9.1Level: LLTClassification code 10025054

• Registration Number: EUCTR2008-004330-24-IT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-31
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Patients with Stage IIIB or Stage IV nonsquamous NSCLC will be eligible to be included in the study only if they meet all of the following criteria: [1] they or their legal representative must have signed an informed consent document (ICD) for clinical and translational research; [2] have a histological diagnosis of Stage IIIB (not amenable to curative treatment) or IV NSCLC other than predominantly squamous cell histology (will subsequently be referred to as ``nonsquamous`` NSCLC for ease of reference) (Protocol Attachment S104.6); [3] have biological tissue available for detection of EGFR expression on tumor tissue; [4] have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for NSCLC. Previous adjuvant chemotherapy is allowed if terminated ≥1 year prior to enrollment; [5] prior chest irradiation is allowed provided it was terminated at least 12 weeks prior to study entry; [6] prior radiation therapy is allowed to less than 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. Prior radiation therapy must be completed at least 2 weeks prior to Day 1 of Cycle 1. Patients must have recovered from the acute toxic effects of radiation therapy prior to Day 1 of Cycle 1; [7] have measurable disease as defined by RECIST. Target lesions must not be in an irradiated area (Therasse et al. 2000) (Protocol Attachment S104.4); [8] males and females at least 18 years of age; [9] have a performance status of 0 or 1 on the ECOG scale (Oken et al. 1982)(Protocol Attachment S104.3); [10] have adequate organ function as follows: Adequate bone marrow reserve: white blood cell count ≥3 × 109/L, absolute neutrophil (segmented and bands) count ≥1.5 × 109/L, platelet count ≥100 × 109/L, and hemoglobin ≥9.0 g/dL; Hepatic: bilirubin ≤1.5 × upper limit of normal (ULN); alkaline phosphatase, alanine transaminase, and aspartate transaminase ≤2.5 × ULN (≤5 × ULN with liver metastases); Renal: creatinine ≤1.5 × ULN, and calculated creatinine clearance ≥45mL/min based on the Cockcroft-Gault formula (Cockcroft and Gault 1976); These tests must be performed within 7 days prior to Day 1 of Cycle 1. [11] male patients must agree to use a reliable method of birth control during the study and for 6 months following the last dose of study drug; [12] eligible female patients: are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a serum or urine pregnancy test within 7 days prior to Day 1 of Cycle 1, and agree to use a reliable method of birth control during the study and for 6 months following the last dose of study drug; are women not of childbearing potential due to surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal; are postmenopausal women, defined as women age 45 years or older with an intact uterus who have not taken hormones or oral contraceptives within the last 6 months, who have had either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) values >40 mIU/mL; [13] have an estimated life expectancy of at least 12 weeks; [14] are able to comply with study and/or follow-up procedures.
Are the trial subjects under 18? no
Number of subjects for this

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria: [15] have symptomatic central nervous system (CNS) metastases; [16] have a serious concomitant systemic disorder (for example, tuberculosis or active infection including human immunodeficiency [HIV] syndrome) that, in the opinion of the investigator, would compromise the patient?s ability to adhere to the protocol; [17] have a serious cardiac condition, such as myocardial infarction, angina, or heart disease, as defined by the New York Heart Association Class II, III, or IV, within 6 months prior to Day 1 of Cycle 1; [18] have another active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years; [19] have a history of significant neurologic or psychiatric disorders including dementia, seizures, and bipolar disorder; [20] have peripheral neuropathy of CTCAE Grade 1 or higher; [21] have received treatment within 30 days prior to Day 1 of Cycle 1 with any drug that has not received regulatory approval for any indication at the time of study entry; [22] have had major surgery within 4 weeks prior to study entry; [23] have previously received treatment with transduction inhibitors or EGFR-targeting therapy; [24] are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer; [25] have prior known allergic/hypersensitivity reaction to any of the components of study treatment; [26] are pregnant or breastfeeding; [27] are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin 1.3 grams per day or less, for a 5-day period (8-day period for long-acting agents, such as piroxicam); [28] are unable or unwilling to take folic acid, vitamin B12, or corticosteroid supplementation; [29] have clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to Day 1 of Cycle 1; [30] known drug abuse; [31] recent (within 30 days before enrollment) or concurrent yellow fever vaccination. [32] are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted; [33] are Lilly employees; [34] are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified