ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Vandetanib
Intervention description: infusion; oral
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1690.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; NSCLC

Summary:

      This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in
      treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets
      the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor
      receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial
      growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in
      lung cancer patients who have had their cancer re-appear after treatment with standard
      chemotherapy.

      This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can
      deliver longer improved progression free survival and improved overall survival than
      docetaxel (Taxotere) alone.

      All patients participating this clinical study will receive treatment with docetaxel, a
      commonly used treatment for recurrent non-small cell lung cancer.

      In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF
      agent.

      Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR)
      inhibition, when used with standard chemotherapy, can lead to increased survival in advanced
      non-small cell lung cancer (NSCLC) patients.

      Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib
      (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour
      cells and stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

        Lung cancer patients who answer true to the following statements are eligible to join this
        clinical study.

          -  I have a confirmed diagnosis of locally advanced or metastatic non small cell lung
             cancer (Stage IIIb - IV)

          -  I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab)
             in first line NSCLC is allowed.

        Exclusion Criteria:

        Lung cancer patients who answer true to the following are NOT eligible to join this
        clinical study.

          -  I do not have non small cell lung cancer (NSCLC)

          -  I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel
             is acceptable.

          -  I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd
             line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744),
             Alimta (pemetrexed) are not eligible)

          -  I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib,
             sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line
             non small cell lung cancer is permitted.

          -  I have a history of uncontrolled irregular heartbeat

          -  I have a history of high blood pressure which has not been controlled with medication
             If you are unsure of the meaning of the inclusion and exclusion criteria above, please
             contact the call center number for help.