A Phase 2 Study to Evaluate LY2603618 in Combination with Pemetrexed in Patients with Advanced or Metastatic Non-small Cell Lung Cancer - ND

• Conditions: Advanced or metastatic non-squamous second-line Non-small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10029521; MedDRA version: 9.1Level: LLTClassification code 10029522

• Registration Number: EUCTR2009-013787-39-IT
• Lead Sponsor: Eli Lilly and company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Histological or cytological diagnosis of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) which has progressed after first line treatment with a platinum doublet chemotherapy regimen not containing pemetrexed. Previous treatment with biological agents is permitted. [2] Patients must agree to (and be clinically able to undergo) a biopsy of the primary tumor or an accessible metastasis during the baseline Visit (Visit 0). [3] Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 definitions. At least 1 measurable lesion must be outside the field of any allowed prior radiotherapy; see Exclusion Criterion [11]. [4] Have a performance status of &#8804;2 on the Eastern Cooperative Oncology Group (ECOG) scale. [5] Males or females at least 18 years of age. Have adequate organ function including: Hematologic: Absolute neutrophil count (ANC) &#8805;1.5 x 109/L, platelets &#8805;100 x 109/L, and hemoglobin &#8805;9 g/dL. Transfusions are allowed to meet this requirement.Hepatic: Bilirubin &#8804;1.5 times upper limits of normal (ULN), aspartate transaminase (AST) <2.5 times ULN, alanine transaminase (ALT) &#8804;2.5 times ULN. If the liver has tumor involvement, aspartate transaminase (AST) <5 times ULN and ALT equaling &#8804;5 times ULN are acceptable. Patients may have endoscopic or radiologic stenting to treat biliary obstructions. If so, then bilirubin must return to <1.5 times ULN, alkaline phosphatase (AP) and aspartate transaminase (AST) to <5 times ULN, and ALT to &#8804;5 times ULN prior to enrollment. Renal: Calculated creatinine clearance (Cockroft-Gault formula; see Protocol Attachment JMMD.4), greater than or equal to 45 mL/min.Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow (Christy and Eckerman 1987) and patients must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study entry. At least 1 measurable lesion must be outside the previous radiotherapy field.
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

Are currently enrolled in, or discontinued within the last 28 days from, a clinical trial involving the use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [14] Have serious preexisting medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris or uncontrolled diabetes mellitus).Have 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 therapy). A screening computed tomography (CT) scan or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.

Study & Design

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