Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin with Concurrent Thoracic Radiotherapy, in Patients with Unresectable Locally-Advanced Stage III, Non-Squamous, Non-Small Cell Lung Cancer - A Study in Patients with Non-Small Cell Lung Cancer

Phase 1

Conditions: on-small Cell Lung Cancer
MedDRA version: 9.1Level: LLTClassification code 10029520Term: Non-small cell lung cancer stage IIIA
MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB

Registration Number: EUCTR2009-011739-11-FR

Lead Sponsor: Eli Lilly and Company Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

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 < or = 35%.
[11]For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding.
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
[12] Have not received prior systemic anticancer therapy for NSCLC. No prior adjuvant chemotherapy is allowed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 < or = 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
[18]Are receiving concurrent administration of any other antitumor therapy.
[19]Have had weight loss > 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Progression free survival at 1 year;Secondary Objective: •Objective tumor response rate<br>•Overall survival (OS) <br>•Safety and tolerability (acute and late toxicity)<br>;Primary end point(s): 1 year progression free survival

Secondary Outcome Measures

Name	Time	Method

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