Advanced or metastatic non-squamous second-line Non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10029521 MedDRA version: 9.1 Level: LLT Classification code 10029522
Conditions
Interventions
Product Name: ChK1 inhibitor
Product Code: LY2603618
Pharmaceutical Form: Powder for infusion*
CAS Number: 911222-45-2
Current Sponsor code: LY2603618
Concentration unit: mg/m2 milligram(s)/square met
Sponsors
Eli Lilly and company
Eligibility
Sex/Gender
All
Inclusion criteria
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 ≤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) ≥1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥9 g/dL. Transfusions are allowed to meet this requirement.Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), aspartate transaminase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to estimate the overall response rate (ORR) for patients receiving pemetrexed in combination with LY2603618 for advanced or metastatic non-small cell lung cancer (NSCLC) after 1 prior therapy for their disease;Secondary Objective: To characterize the safety and toxicity profile of LY2603618 when administered in combination with pemetrexed in the above patient population. To estimate time-to-event variables, such as progression free survival (PFS) and duration of response. To evaluate the clinical benefit rate (clinical benefit rate = best response of stable disease [SD] + partial response [PR] + complete response [CR] per Response Evaluation Criteria in Solid Tumors [RECIST]). To further evaluate the pharmacokinetics of LY2603618 in combination with pemetrexed. To determine if MAGEA2 and CDKN2A gene expression correlates with tumor protein 53 (TP53) mutation status and/or p53 expression in tumor biopsies.;Primary end point(s): Objective response is an appropriate primary endpoint in a single arm trial. Progression-free survival, duration of response, and clinical benefit are accetable secondary endpoints and are clinically relevant in patients with life-threatening diseases | — |
Countries
Italy
Outcome results
None listed