An Open-Label, Multicenter, Randomized, Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed with or without Cixutumumab as First-Line Therapy in Patients with Advanced Nonsquamous Non-Small Cell Lung Carcinoma - ND

Phase 1

• Conditions: Advanced nonsquamous non-small cell lung carcinoma; MedDRA version: 9.1Level: LLTClassification code 10029522

• Registration Number: EUCTR2010-024014-60-IT
• Lead Sponsor: Eli Lilly and Company Limited, Indianapolis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-22
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

[1] The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC. [2] The patient has Stage IV disease (AJCC Staging Manual, Seventh Edition; Edge et al. 2010) at the time of study entry. [3] Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade =1 central nervous system (CNS) hemorrhage based on pretreatment magnetic resonance imaging (MRI) or intravenous (IV) contrast computed tomography (CT) scan (performed within 21 days before randomization). [4] The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1) guidelines (Eisenhauer et al. 2009; Attachment 6). [5] The patient is =18 years old. [6] The patient has an ECOG performance status (PS) of 0 or 1 (Oken et al. 1982; Attachment 7). [7] If the patient received prior adjuvant chemotherapy, the last dose of adjuvant treatment was administered at least 6 months prior to randomization. [8] The patient has adequate organ function, as evidenced by the following: • Adequate bone marrow reserve: absolute neutrophils (segmented and bands) count (ANC) =1500 cells/µL, hemoglobin =9.5 g/dL, and platelets =100000 cells/µL. • Hepatic: bilirubin =1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 times ULN (or =5 times the ULN in the presence of known liver metastases). • Renal: The patient has adequate renal function as defined by serum creatinine =1.2 times the institutional ULN. If serum creatinine is above 1.2 times the ULN, the patient’s creatinine clearance must be =45 mL/min. [9] The patient has fasting serum glucose =100 mg/dL, and hemoglobin A1C =6%. If baseline nonfasting glucose =100 mg/dL, fasting glucose measurement is not required. [10] Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug. [11] Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug. [12] The patient has the ability to understand and the willingness to sign a written informed consent form (ICF). [13] Patients with prior radiation therapy may be eligible for this study if they meet the following guidelines: • Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), but should have been limited and must not have included whole pelvis radiation. • Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). • Prior thoracic radiotherapy must be completed 30 days before study enrollment. • Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. • Palliative extrathoracic radiotherapy to preexisting lesions may continue on study; however, these lesions may not be included as sites of measurable disease. [14] The pa

Exclusion Criteria

Patients must not have an uncontrolled intercurrent illness, leptomeningeal disease, or active infection requiring parenteral therapy.

Study & Design

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