Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
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ClinicalTrials.gov Identifier: NCT00777179 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : July 8, 2011
Last Update Posted : October 10, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC | Drug: Vandetanib Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 117 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Vandetanib |
Drug: Vandetanib
Tablet, oral, daily
Other Name: Zactima TM |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo |
- Progression-free Survival (PFS) Rate at 3 Months [ Time Frame: 12 weeks ]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) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.
- Overall Survival (OS) [ Time Frame: Every 12 weeks unless the patient withdraws consent ]Overall survival (OS) defined as the median time from randomization to death from any cause.
- Disease of Response (DOR) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]
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
- Objective Response Rate (ORR) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
- Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
- WHO PS 0-1
- No prior radiotherapy to chest, immunotherapy or biologic therapy
Exclusion Criteria:
- Mixed small cell and non small-cell lung cancer history.
- Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is not permitted.)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777179
Korea, Republic of | |
Research Site | |
CheongJu, Republic of Korea, Korea, Republic of | |
Research Site | |
Gyeonggi-do, Republic of Korea, Korea, Republic of | |
Research Site | |
Gyeongsangnam-Do, Republic of Korea, Korea, Republic of | |
Research Site | |
Incheon, Republic of Korea, Korea, Republic of | |
Research Site | |
Seoul, Republic of Korea, Korea, Republic of |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Genzyme, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00777179 |
Other Study ID Numbers: |
D4200C00077 |
First Posted: | October 22, 2008 Key Record Dates |
Results First Posted: | July 8, 2011 |
Last Update Posted: | October 10, 2016 |
Last Verified: | August 2016 |
Vandetanib, NSCLC, Maintenance, Phase II |
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |