Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Pemetrexed and Cisplatin plus Enzastaurin versus Pemetrexed and Cisplatin plus Placebo in Chemonaive Patients with Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer - N/A

• Conditions: advanced, unresectable, or metastatic (stage IIIB or IV) nonsquamous non-small cell lung cancer

• Registration Number: EUCTR2006-005306-31-BE
• Lead Sponsor: Eli Lilly and Company limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients are eligible to be included from the study if they meet all of the following criteria:
[1] Have histologic or cytologic diagnosis of advanced NSCLC (Stage IIIB disease with pleural effusion and/or positive supraclavicular nodes, or Stage IV disease)
In addition, patients enrolling in Part 2 of the study should have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
[2] No prior systemic chemotherapy, pleurodesis with chemotherapy, immunotherapy, targeted or biological therapy for this disease
[3] Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, OR nonmeasurable disease, defined according to RECIST
[4] Prior radiation therapy is allowed to <25% of the bone marrow; however prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment. Patients must have recovered from the acute toxic effects prior to study enrollment
[5] Have a performance status of 0 or 1 on the Eastern Cooperative Oncology group (ECOG) scale
[6] Must sign an informed consent document (or legal representative has given informed consent)
[7] Male or female patients at least 18 years of age
[8] Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and his or her health care team, during the study and for 6 months following the last dose of study treatment
[9] Have adequate organ function as follows:
• Hepatic: total bilirubin =1.5 times the upper limit of normal (× ULN); alanine transaminase (ALT) alkaline phosphatase (AP) and aspartate transaminase (AST) =2.5 ×ULN (=5 × ULN, with hepatic metastases).
• Renal: serum creatinine =1.5 × ULN; creatinine clearance =45mL/min (calculated according to Cockcroft and Gault 1976
• Adequate bone marrow reserve: platelet count =100 × 109/L, absolute neutrophil count (ANC) =1.5 x 109/L, and hemoglobin =9.0 g/dL
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

Patients will be excluded from the study if they meet any of the following criteria:
[10] Have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
[11] Have active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy
[12] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
[13] Have documented central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study treatment). A screening CT or MRI before enrollment in the absence of a clinical suspicion of brain metastases is not required.
[14] Have had myocardial infarction occurring <6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications (refer to the New York Heart Association Class III or IV)
[15] Have peripheral neuropathy of NCI CTCAE Grade 2 or above
[16] Are unable or unwilling to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
[17] Are pregnant or breast feeding
[18] Are unable to swallow tablets.
[19] Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
[20] Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study enrollment.
[21] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose < or =1.3 g per day, for a 5-day period (8 day period for long-acting agents, such as piroxicam).
[22] Inability or unwillingness to take folic acid or vitamin B12 supplementation or corticosteroids.

Study & Design

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