Health Condition 1: null- Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) patients
Conditions
Interventions
Intervention1: Gemcitabine injection: Dose of 1250 mg/m² intravenously by infusion for 30 min on 1st and 8th day of each 21days chemotherapy cycle. Each subject will receive 6 cycles of chemotherapy.
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject/LAR willing to sign an IEC/IRB approved ICF before performing any study specific procedures or tests. 2.Male and female subjects aged between 18 to 75 years. 3.Subjects with histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC in squamous or undetermined cells. 4.Subject who had at least one bi-dimensionally measurable lesion. 5.Subjects who have not had prior chemotherapy. 6.At least 4 weeks should have elapsed since subjects received any radiation therapy(previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields). 7.Subjects with an ?Eastern Cooperative Oncology Group? scale performance status less than or equal to 2. 8.Subjects with a screening hematology and blood biochemistry values of: a.WBC greater than 4,000/mL b.ANC greater than 1,500/mL c.Platelets greater than 100,000/mL d.Hb greater than or equal to 9g/dL e.ALT/AST less than or equal to 5 times x UNL f.Bilirubin less than or equal to 1.5times x UNL g.Creatinine less than or equal to 1.25 times x UNL h.Calcium level within the normal range (9-11mg/dL) 9.Men and women of childbearing potential who consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter. 10.Subjects must be willing and must be able to comply with scheduled visits and procedures. 11.Life expectancy greater than 6 months (as per the PI?s discretion).
Exclusion criteria
Exclusion criteria: 1.Subjects who had central nervous system (CNS) metastases and subjects with any psychiatric disorders. 2.Subjects with previous or concurrent malignancy other than lung cancer, with the exception of non melanoma skin cancer or curatively treated carcinoma in situ of the uterine cervix. 3.Subjects who have a history of any of the following conditions within 6 months prior to screening visit: a.Clinically significant myocardial infarction or severe/unstable angina pectoris. b.New York Heart Association (NYHA) class III or IV, congestive heart failure. c.Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism. 4.Subjects who are on treatment with a.Hormonal therapy, radiation therapy, immunotherapy, biological therapy, any investigational agent and major surgery within 4 weeks before screening visit. b.Herbal preparations or any alternative medicine within 2 weeks prior to screening visit or during the study. 5.Subjects with concurrent serious infection especially tuberculosis. 6.Subjects with a history of preexisting renal and hepatic impairment (h/o hepatitis, alcoholism or liver cirrhosis). 7.Subjects with vascular (peripheral vasculitis and gangrene) and skin disorders. 8.Subjects who are planning or in need for a major surgical procedure or radiotherapy (RT) during the study. 9.Subjects who are pregnant or breast feeding. 10.Subjects with known history of hypersensitivity reactions to investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Objective Response Rate (ORR) by RECIST criteria Version 1.1 Timepoint: Measured at baseline, before initiation of 4th cycle (Day64), and at the end of 6th cycle (Day113) and if required at the end of the study (24 weeks or at least 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant vital examination or lab investigationsTimepoint: During study period of 6 months;Incidence of adverse eventsTimepoint: During study period of 6 months;Incidence of drug related adverse eventsTimepoint: During study period of 6 months;Time to Progression (TTP) by RECIST criteria version 1.1Timepoint: Measured at baseline, before initiation of 4th cycle (Day64), and at the end of 6th cycle (Day113) and if required at the end of the study (24 weeks or at least 6 months) | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Medical Monitor
Outcome results
None listed