Non-small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Trade Name: Alimta
Product Name: pemetrexed
Product Code: LY231514
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: L
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB NSCLC. Squamous cell and/or mixed small cell, non-small cell histology is not permitted. [2]Have an ECOG PS of 0 or 1. [3]Previous radiation therapy is allowed, but should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the patient’s bone marrow. Patients must have recovered from the toxic effects of radiation treatment prior to study enrollment. Prior radiotherapy must be completed 30 days before study entry. [4]Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0. Positron emission tomography (PET) scans and ultrasounds may not be used. [5]Estimated life expectancy of at least 12 weeks. [6]Patient compliance and geographic proximity that allow adequate follow-up. [7]Adequate organ function, including the following: Adequate bone marrow reserve, adequate hepatic, pulmonary and renal functions. [8]Patients must sign an ICD. [9]Patients must be at least 18 years of age. [10]Patients must have completed a 3-D plan, and the attending physician must have reviewed and approved the dose volume histograms with a total lung V20 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [13]Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry. [14]Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15]Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [16]Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. [17]Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score 10% over the previous 3 months before study entry. [20]Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose < or = 1.3 grams per day, for at least 2 days before (5 days for long-acting agents), the day of, and for at least 2 days after administration of pemetrexed. [21]Are unable or unwilling to take folic acid or vitamin B12 supplementation. [22]Are unable or unwilling to take corticosteroids. [23]Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [24]Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products. [25]Have evidence of clinical hearing loss. [26]Have clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival at 1 year;Secondary Objective: • Objective tumor response rate • Overall survival (OS) • Safety and tolerability (acute and late toxicity) ;Primary end point(s): 1 year progression free survival | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed