Phase 3 Study of Pemetrexed, Cisplatin, andRadiotherapy Followed by Consolidation Pemetrexedversus Etoposide, Cisplatin, and Radiotherapy Followedby Consolidation Cytotoxic Chemotherapy of Choice inPatients with Unresectable, Locally Advanced, Stage IIINon-Small Cell Lung Cancer Other than PredominantlySquamous Cell Histology - JMIG

• Conditions: patients with locally advanced, unresectable/inoperable, Stage III, nonsquamous NSCLC without malignant pleural/pericardial effusion; 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: EUCTR2008-001170-32-FR
• Lead Sponsor: Eli Lilly and Company limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-22
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

[1]Present with histological proven or cytological diagnosis of NSCLC that is defined as nonsquamous (squamous cell histology and/or mixed small cell, non-small cell histology is not permitted)
[2]Unresectable Stage IIIA or IIIB NSCLC (without malignant pleural/pericardial effusion).
[3]Have an ECOG functional status score of 0 or 1
[4]Have tumor lesion measurable according to Response Evaluation Criteria in Solid Tumors
[5]Have adequate pulmonary function defined as in the protocol
[6]Have normal organ and marrow function as defined in the protocol
[7]Weight loss < or = 5% in the preceding 3 months
[8]Estimated life expectancy > 12 weeks
[9]Age > or = 18 years
[10]Signed informed consent from the patient
[[11]For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine 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]Are compliant with study procedures and should live in a geographic proximity that facilitates adequate follow-up.

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 uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
[14]Have myocardial infarction within the preceding 6 months or symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled cardiac arrhythmia
[15]Have received treatment within the last 30 days with any other investigational agents that have not received regulatory approval for any indication at the time of study entry
[16]Have disease that is currently amenable to surgery
[17]Had prior thoracic or head/neck radiation. However, other prior radiotherapy is allowed. Patients must have recovered from the toxic effects of the treatment prior to study enrollment. Patients may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow (Cristy and Eckermann 1987)
[18]Patients whose radiation treatment plans encompass a volume of whole lung receiving > or = 20 Gy in total (V20) of more than 35% of lung volume
[19]Concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Patients cannot have had either breast cancer or melanoma even if more than 5 years previously. Curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix are allowed
[20]Are pregnant, breast feeding, or unwilling to use adequate contraception
[21]Patients with immune deficiency (for example, HIV positive)
[22]Are unable to interrupt aspirin at a dose < or = 1.3 g/day or other nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
[23]Are unable/unwilling to take folic acid, vitamin B12, and dexamethasone
[24]Have contraindication or rejection of the use of corticosteroids within 30 days of enrollment, or concurrent yellow fever vaccination (within 30 days of study enrollment)
[25]Have evidence of clinical hearing loss.
[26] Known hypersensitivity to pemetrexed, cisplatin, etoposide or any of
the excipients in these medicinal products.

Study & Design

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