advanced, unresectable, or metastatic (stage IIIB or IV) non-small cell lung cancer
Conditions
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
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) not amenable to curative treatment [2] No prior systemic chemotherapy, pleurodesis, 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Those objectives are applicable to Part 2 only: o Compare the response rates (RR) and the disease control rates (DCR) between treatment arms according to Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines o overall survival (OS) o duration of disease control (DDC) o duration of response (CR, PR) o time to worsening of symptoms (TWS) using the Lung Cancer Symptom Scale (LCSS) o safety and toxicity profile of study treatments o to assess biomarkers relevant to enzastaurin, pemetrexed and the disease state, as well as their correlation to clinical outcome ;Primary end point(s): The primary endpoint for Part 1 (Safety lead in) is to evaluate the safety of the combination of enzastaurin plus pemetrexed and cisplatin. The primary endpoint for Part 2 is to compare progression-free survival (PFS) between the two arms of treatment. PFS is defined as the time from the date of study enrolment to the first date of objectively determined progressive disease or death from any cause.;Main Objective: The study will be conducted in 2 parts: • Part 1: a single-arm, unblinded, safety lead in. • Part 2: a multiple-site, randomized, double-blind, placebo-controlled study. The objective of the Safety lead in, Part1, is to evaluate the safety of enzastaurin plus pemetrexed and cisplatin in the first-line treatment of patients with advanced, unresectable (stage IIIB) or metastatic (Stage IV) NSCLC The objective of Part 2 (randomized, double-blind, placebo-controlled, phase 2 study) is to compare first-line treatment with pemetrexed and cisplatin plus enzastaurin versus pemetrexed and cisplatin plus placebo, followed by maintenance enzastastaurin or placebo, in terms of progression-free survival (PFS) | — |
Countries
Belgium, Germany
Outcome results
None listed