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NCT00777179
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
Phase 2 trial testing Vandetanib in NSCLC in 117 participants. Completed in 1 December 2011.
1 January 2010
Quick facts
| Lead sponsor | Genzyme, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 1 October 2008 |
| Primary completion | 1 January 2010 |
| Estimated completion | 1 December 2011 |
| Sites | 5 locations across South Korea |
Drugs / interventions tested
- Vandetanib (VANDETANIB) — full drug profile →
- Placebo
Conditions studied
- NSCLC — all drugs for NSCLC →
Sponsor
Genzyme, a Sanofi Company — full company profile →
Who can join
18 and older, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Single-agent maintenance therapy for advanced non-small cell lung cancer (NSCLC): a systematic review and Bayesian network meta-analysis of 26 randomized controlled trials.
Wang Q, Huang H, Zeng X, Ma Y, et al · · 2016 · cited 9× · PMID 27781159 · DOI 10.7717/peerj.2550 -
Current status of vandetanib (ZD6474) in the treatment of non-small cell lung cancer.
Flanigan J, Deshpande H, Gettinger S. · · 2010 · cited 9× · PMID 20859451 · DOI 10.2147/btt.s7223
Verify or expand the search:
- PubMed search for NCT00777179
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vandetanib
Trials testing the same drug.
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- NCT06482086 — Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer · Phase 2 · recruiting
- NCT03630120 — Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer · Phase 2 · terminated
- NCT02495103 — Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Rena · Phase 1, PHASE2 · terminated
- NCT01823068 — Vandetanib in Advanced NSCLC With RET Rearrangement · Phase 2 · completed
Other recruiting trials for NSCLC
Currently open trials in the same condition.
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Other Genzyme, a Sanofi Company trials
Trials by the same sponsor.
- NCT06666413 — China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD · Phase 4 · recruiting
- NCT05164055 — Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) · Phase 4 · active not recruiting
- NCT05134571 — China Post-marketing Surveillance (PMS) Study of Aldurazyme® · Phase 4 · completed
- NCT05054387 — China Post-marketing Surveillance (PMS) Study of Fabrazyme® · Phase 4 · completed
- NCT04676373 — Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00777179 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genzyme, a Sanofi Company
- Last refreshed: 29 August 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00777179.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing