Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy

ClinicalTrials.gov ID

NCT00364351

Acronym / sponsor ID

D4200C00057

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, NSCLC

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

1,574 participants (actual)

Lead sponsor

Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)

Study start

Aug 2006

Primary completion

Sep 2008 (actual)

Study completion

Nov 2016 (actual)

First posted

15 Aug 2006 (estimated)

Results

Posted 24 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Progression-Free Survival (PFS)

   Time frame: progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.

   Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Results publication: PubMed 21282542Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.
• Derived from this study: PubMed 40785488Mishina A, Zhudenkov K, Helmlinger G, Peskov K. A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC. CPT Pharmacometrics Syst Pharmacol. 2025 Dec;14(12):1970-1981. doi: 10.1002/psp4.70095. Epub 2025 Aug 11.
• Derived from this study: PubMed 25881079Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
• Vandetanib\_study\_57\_ZEST\_CSP\_redacted\_SECURELink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

153 sites in 22 countries: see every site and its status.