Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Vandetanib

Placebo

Clinical Sciences & Operations

This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.

Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.

Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.

Overall survival (OS) defined as the median time from randomization to death from any cause.

Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.

Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response

Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.

Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.

Genzyme, a Sanofi Company

Total

Median (min-Max Range)

Age, Customized

Sex: Female, Male

Smoker

Non-smoker

Smoking history

Partial Response (PR)

Stable Disease (SD)

completion of 4 cycles of chemotherapy of gemcitabine (1,000mg/m\^2/day or 1,250mg/m\^2/day on day 1 and 8) and cisplatin (70mg/m\^2/day\~80mg/m\^2/day on day 1) every 3 weeks and have shown responses (CR, PR) or stable disease (SD) by RECIST 1.0.

Overall response at screening

WHO PS (0: Fully active, able to carry out all usual activities without restrictions and without the aid of analgesia. 1: Restricted in strenuous activity, but ambulatory and able to carry out light work or pursue a sedentary occupation. This group also contains subjects who are fully active, as in grade 0, but only with the aid of analgesics.)

WHO Performance status

Adenocarcinoma

Squamous cell carcinoma

Other

Histology

Stage IIIb

Stage IV

Classification (Stage IIIb: Any T - N3 - M0 or T4 - Any N - M0, Stage IV: Any T - Any N - M1)

Classification of lung tumor stage

Trial Transparency Team

The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.

Spots Global Cancer Trial Database for Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial