Advanced squamous non small cell lung cancer MedDRA version: 18.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
ImClone LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has histologically or cytologically confirmed squamous NSCLC. 2. The patient has Stage IV disease (per the AJCC Staging Manual, Seventh Edition[40]; please see Appendix 2) at the time of study entry. 3. Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0)[41] (patients with only truly nonmeasurable disease are not eligible). 4. The patient is = 18 years of age. 5. The patient has resolution to Grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia). 6. The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2. 7. The patient has adequate hepatic function as defined by a total bilirubin = 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) = 5.0 x the ULN in the presence of liver metastases or = 2.5 x the ULN in the absence of liver metastases. 8. The patient has adequate renal function, defined by serum creatinine = 1.2 x the ULN or calculated creatinine clearance > 50 mL/minute. 9. The patient has adequate hematologic function, as evidenced by white blood cell count = 3000/µL, an absolute neutrophil cell count (ANC) = 1500/µL, hemoglobin = 9.5 g/dL, and platelets = 100,000/µL. 10. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 432
Exclusion criteria
Exclusion criteria: 1. The patient has nonsquamous NSCLC (adenocarcinoma/large cell or other). 2. The patient has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor. 3. The patient has received previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization). 4. The patient has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization. 5. The patient has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed). 6. The patient has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible. 7. The patient has superior vena cava syndrome contraindicating hydration. 8. The patient has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure (New York Heart Association III or IV). 9. The patient has experienced myocardial infarction within 6 months prior to randomization. 10. The patient has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus. 11. The patient has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance. 12. The patient has any NCI-CTCAE Version 3.0 Grade = 2 peripheral neuropathy. 13. The patient has significant third space fluid retention, requiring repeated drainage. 14. The patient has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient’s ability to complete the study or sign an informed consent document. 15. The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments. 16. The patient is pregnant or breastfeeding. 17. The patient has a known history of drug abuse. 18. The patient has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for = 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: The primary objective of this study is to evaluate the overall survival (OS) in patients with Stage IV squamous NSCLC (per the AJCC Staging Manual, Seventh Edition) treated with IMC-11F8 plus gemcitabine-cisplatin chemotherapy (Arm A) versus gemcitabine-cisplatin chemotherapy alone (Arm B) in the first-line metastatic setting.;Secondary Objective: Secondary Objectives: • To evaluate progression-free survival (PFS) in each arm • To evaluate the objective response rate (ORR) in each arm • To evaluate the time to treatment failure (TTF) in each arm • To evaluate the safety profile of IMC-11F8 in combination with gemcitabine-cisplatin chemotherapy • To evaluate the pharmacokinetics (PK) of IMC-11F8 (Arm A only) • To determine the immunogenicity of IMC-11F8 (Arm A only) • To evaluate Health Status ;Primary end point(s): Overall survival (OS) events ;Timepoint(s) of evaluation of this end point: The final efficacy analysis will be performed when at least 844 deaths are observed. No interim analysis is planned. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival (PFS) • Objective response rate (ORR) • Time to treatment failure (TTF) • Safety endpoints (occurrence of at least one adverse event within a subject, vital sign parameters, laboratory parameters) • Health Status (EQ-5D Index Score and VAS-Score, LCSS Index Score) • PK parameters • Immunogenicity (development of antibodies against IMC-11F8);Timepoint(s) of evaluation of this end point: The analysis of the secondary endpoints will be adjusted by the stratification factors. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Croatia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed