Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma) NOTE: Mixed tumors with small cell carcinoma and aplastic carcinoma are not eligible • Stage IIIA and Stage IIIB at diagnosis excluding patients with pleural effusion at the time of randomization • Life expectancy of at least 6 months • ECOG performance status of 0 or 1 (Post-text suppl. 1) • Weight loss = 10% in the 6 months before diagnosis of NSCLC • Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization. • Adequate bone marrow reserve defined as white blood cell (WBC) = 3500mm3, neutrophils = 1500 mm3, platelets = 100,000 mm3, Hb = 9 g/dL • Able and willing to sign informed consent 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
Exclusion criteria: • Patients with NSCLC with pleural effusion at the time of randomization • Patients who received any prior bisphosphonates in past 12 months • Presence of metastasis • Patients with current malignancy within past 5 years other than NSCLC (exceptions include treated melanoma, ductal carcinoma in situ of the cervix or other cancer cured by reception alone) • Patients who have received radiotherapy = 3 weeks before randomization must have recovered from any adverse events occurring during radiotherapy • Previous thoracotomy must have been performed = 3 weeks prior to randomization and patient must have recovered. • Any previous radiotherapy completed 3mg/dL) • Corrected serum calcium < 8.0 mg/dL • Known hypersensitivity to Zometa or other bisphosphonates • Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including: - Uncontrolled infections - Uncontrolled Type 2 Diabetes Mellitus - Diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction - Cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up • Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study • More than 8 months from the start of the primary antitumor treatment • Patients in whom the primary antitumor treatment is still ongoing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of Zometa in delaying disease progression, disease recurrence or death in patients with locally advanced, stage IIIA and IIIB NSCLC. The primary endpoint is progression free survival. Patients in the treatment arm will receive ZOMETA every 3-4 weeks. Patients in the control arm will not receive ZOMETA treatment until development of bone metastases.;Secondary Objective: Secondary objectives include evaluation of: • Time to occurrence of bone metastases • Rate of bone metastases (irrespective whether symptomatic or not ) at 6, 12, 18 and 24 months • Time to disease progression (TTP), censoring non-cancer deaths • Risk of skeletal related events (SREs) at 12 and 24 months from study entry based on multiple event analysis by the Anderson-Gill method and rate of SRE at 12 and 24 months (proportion of patients having experienced at least one SRE) Skeletal-related events (SREs) are defined as: - radiation therapy to bone - surgery to bone - spinal cord compression events - pathologic bone fracture events - time to first SRE - survival at 12 and 24 months • Time to occurrence of bone metastases in the subgroup of high risk patients (high risk assessed by BSP expression in the primary tumor). • Rate of bone metastases ;Primary end point(s): The primary objective of the study is to evaluate the efficacy of Zometa in delaying disease progression or recurrence or death in patients with locally advanced, stage IIIA and IIIB NSCLC. The primary endpoint is progression free survival. Patients in the treatment arm will receive ZOMETA every 3-4 weeks. Patients in the control arm will not receive ZOMETA treatment until development of bone metastases. | — |
Countries
Belgium, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed