Non Small Cell Lung CancerPhase 3ZEALNCT00418886
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients
A Phase 3 study testing Vandetanib and Pemetrexed in people with Non Small Cell Lung Cancer and Lung Cancer, run by Genzyme, a Sanofi Company at 110 sites in 21 countries.
Trial summary
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- Vandetanib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 698 participants
- Where
- 110 sitesin 21 countries
- Study dates
- Jan 2007to 14 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Female or male aged 18 years or above
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (stage IIIB or IV) on entry into study
- Failure of 1st line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) or subsequent relapse of disease following 1st line therapy
- WHO Performance status 0 - 2
- One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria. Previously irradiated lesions will not be considered measurable.
- Life expectancy of 12 weeks or longer
- Negative pregnancy test for women of childbearing potential only
Who cannot join
- Mixed small cell and non-small cell lung cancer histology
- Patients have received 2nd-line or subsequent anti-cancer therapy
- Prior treatment with pemetrexed
- Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] is permitted)
- Known or suspected brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days
- The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation
Show all 29Show fewer
- The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 3 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin, and suramin)
- Major surgery within 4 weeks before entry, or incompletely healed surgical incision
- Neutrophils <1.5 x 109/L or platelets <100 x 109/L
- Serum bilirubin >1.5 x the upper limit of reference range (ULRR)
- Creatinine clearance <50 ml/min calculated by either Cockcroft -Gault, 24 hours urine collection, EDTA scan or other validated methods
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR in the absence of liver metastases, or > 5 x ULRR in the presence of liver metastases
- Alkaline phosphatase (ALP) >2.5 x ULRR in the absence of liver metastases, or >5 x ULRR in the presence of liver metastases
- Current active gastrointestinal disease that may affect the ability of the patient to absorb ZD6474 or tolerate diarrhoea
- 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
- Any unresolved toxicity greater than CTCAE Grade 2 from previous anti-cancer therapy
- Significant cardiovascular event (e.g., myocardial infarction, superior vena cava [SVC] syndrome), New York Heart Association [NYHA] classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
- History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded
- Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
- QT prolongation with other medications that required discontinuation of that medication
- Presence of left bundle branch block (LBBB)
- QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG (Note: If a patient has QTc interval ≥480 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study) Patients who are receiving a drug that has a risk of QTc prolongation are eligible if QTc is <460 msec.
- Potassium <4.0 mmol/L despite supplementation; serum calcium (or ionized or adjusted for albumin), or magnesium out of normal range despite supplementation
- Women who are pregnant or breast-feeding
- Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function. Drugs that have a risk of QTc prolongation, that in the investigator's opinion cannot be discontinued, are allowed, but only of the QTc is <460 msec
- Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 millimetre of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg)
- Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- Concomitant use of yellow fever vaccine or any live attenuated vaccines
Trial locations and contacts
110 sites in 21 countries.
110 sites in 21 countries
United States23 sites
Research Site
Austin, Texas
Research Site
Baltimore, Maryland
Research Site
Boston, Massachusetts
Research Site
Casa Grande, Arizona
Research Site
Chandler, Arizona
Research Site
Cincinnati, Ohio
Research Site
Farmington, Connecticut
Research Site
Gainesville, Georgia
Research Site
Hilton Head Island, South Carolina
Research Site
Middletown, Ohio
Research Site
Mineola, New York
Research Site
Mount Sterling, Kentucky
Research Site
Orlando, Florida
Research Site
Portland, Maine
Research Site
Rochester, New York
Research Site
Rockville, Maryland
Research Site
Salt Lake City, Utah
Research Site
Sioux City, Iowa
Research Site
Skokie, Illinois
Research Site
St Louis, Missouri
Research Site
Stamford, Connecticut
Research Site
Washington D.C., District of Columbia
Research Site
Winston-Salem, North Carolina
Argentina8 sites
Research Site
Avellaneda
Research Site
Buenos Aires
Research Site
Ciudad de Buenos Aires
Research Site
Córdoba
Research Site
La Plata
Research Site
Ramos Mejía
Research Site
Salta
Research Site
Santa Fe
Israel8 sites
Research Site
Beer-Sheeva
Research Site
Haifa
Research Site
Jerusalem
Research Site
Kfar Saba
Research Site
Petah Tikva
Research Site
Safed
Research Site
Tel HaShomer
Research Site
Tsrifin
Spain8 sites
Research Site
A Coruña
Research Site
Lugo
Research Site
Majadahonda
Research Site
Málaga
Research Site
Mataró(Barcelona)
Research Site
Ourense
Research Site
Santiago de Compostela(A Coru
Research Site
Vigo(Pontevedra)
Australia7 sites
Research Site
Chermside
Research Site
Fitzroy
Research Site
Footscray
Research Site
Heidelberg
Research Site
Randwick
Research Site
St Leonards
Research Site
Wodonga
France5 sites
Research Site
Avignon
Research Site
Lyon
Research Site
Paris
Research Site
Pontoise
Research Site
Strasbourg
Germany5 sites
Research Site
Cologne
Research Site
Hanover
Research Site
Karlsruhe
Research Site
Kassel
Research Site
Leipzig
Italy5 sites
Research Site
Genova
Research Site
Milan
Research Site
Orbassano
Research Site
Roma
Research Site
S.Andrea Delle Fratte
South Africa5 sites
Research Site
Cape Town
Research Site
Durban
Research Site
Johannesburg
Research Site
Port Elizabeth
Research Site
Pretoria
Sweden5 sites
Research Site
Lund
Research Site
Sundsvall
Research Site
Umeå
Research Site
Uppsala
Research Site
Västerås
United Kingdom5 sites
Research Site
Birmingham
Research Site
Edinburgh
Research Site
Leeds
Research Site
Manchester
Research Site
Wolverhampton
Colombia4 sites
Research Site
Bogotá
Research Site
Medellín
Research Site
Pereira
Research Site
Valledupar
Philippines4 sites
Research Site
Cebu City
Research Site
Manila
Research Site
Pasay
Research Site
Quezon City
Belgium3 sites
Research Site
Brussels (Woluwé-St-Lambert)
Research Site
Leuven
Research Site
Liège
Greece3 sites
Research Site
N. Faliro
Research Site
Pátrai
Research Site
Thessaloniki
Mexico3 sites
Research Site
Aguascalientes
Research Site
México
Research Site
Puebla City
Portugal3 sites
Research Site
Lisbon
Research Site
Santa Maria da Feira
Research Site
Setúbal
About this study
Official title: A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.
Read the detailed description
This randomized phase III non-small cell lung cancer clinical trial is studying the effect of Alimta (pemetrexed) plus vandetanib to see how well the combination works compared to Alimta (pemetrexed) alone in patients who have previously been treated for non-small cell lung cancer (NSCLC).
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Being tested
- Vandetanib, Pemetrexed
- Keywords
- NSCLC, Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
Also called ZACTIMA™, ZD6474, SAR390530
oral once daily tablet
PemetrexedDrug
Also called Pemetrexed disodium, Alimta®
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Vandetanib + Pemetrexed Receives: Drug: Pemetrexed |
| 2 | Experimental | Vandetanib + Pemetrexed Receives: Drug: Vandetanib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) in the Overall Population
Median time (in weeks) from randomization 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.
Measured: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Progression-Free Survival in the Female Population
Median time (in weeks) from randomization 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 RECIST assessment.
Measured: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Secondary outcomes (8)
Overall Survival (OS)
The OS is defined as the time from date of randomization until death. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (i.e, their status must be known at the censored date and should not be lost to follow up or unknown).
Measured: Time to death in months
Objective Response Rate (ORR)
The ORR is the number of participants that are responders i.e, those participants with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 6 weeks, progressive disease (PD) or NE.
Measured: Each participant was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Disease Control Rate (DCR)
The DCR is defined as the number of patients who achieved disease control at 6 weeks following randomization. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks.
Measured: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Duration of Response (DoR)
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment).
Measured: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score
TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.
Measured: LCSS questionnaires are to be administered every 3 weeks after randomization
Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The ASBI is derived from 6 of LCSS's 9 items.
Measured: ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomization
Longitudinal Analysis of Lung Cancer Symptom Scale Total Score
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all 9 visual analogue participant scales from "none" [0 millimeter (mm)] to "as much as it could be" (100 mm).
Measured: LCSS questionnaires are to be administered every 3 weeks after randomization
Longitudinal Analysis of Average Symptom Burden Index Score
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the 6 symptom visual analogue patient scales from "none" (0 mm) to "as much as it could be" (100 mm).
Measured: ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418886
- Sponsor's protocol ID
- D4200C00036
- Other IDs
- EUDRACT No. 2006-003695-35, LPS15296
- Acronym
- ZEAL
- Status last verified
- Dec 2024
- First submitted
- 4 Jan 2007
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
de Boer RH, Arrieta O, Yang CH, Gottfried M, Chan V, Raats J, de Marinis F, Abratt RP, Wolf J, Blackhall FH, Langmuir P, Milenkova T, Read J, Vansteenkiste JF. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2011 Mar 10;29(8):1067-74. doi: 10.1200/JCO.2010.29.5717. Epub 2011 Jan 31.
PubMed 21282537Platt 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.
PubMed 25881079
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT00418886
- Acronym / sponsor ID
- ZEAL / D4200C00036
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Keywords
- NSCLC, Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2007 (actual)
- Primary completion
- Sep 2008 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.
Detailed description
This randomized phase III non-small cell lung cancer clinical trial is studying the effect of Alimta (pemetrexed) plus vandetanib to see how well the combination works compared to Alimta (pemetrexed) alone in patients who have previously been treated for non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PemetrexedPlacebo Vandetanib + Pemetrexed |
| 2 | Experimental | Drug: Vandetanib, Drug: PemetrexedVandetanib + Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent
- Female or male aged 18 years or above
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (stage IIIB or IV) on entry into study
- Failure of 1st line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) or subsequent relapse of disease following 1st line therapy
- WHO Performance status 0 - 2
Key exclusion criteria (29 listed)
- Mixed small cell and non-small cell lung cancer histology
- Patients have received 2nd-line or subsequent anti-cancer therapy
- Prior treatment with pemetrexed
- Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] is permitted)
- Known or suspected brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VandetanibAlso: ZACTIMA™, ZD6474, SAR390530oral once daily tablet | Drug | 2 |
| PemetrexedAlso: Pemetrexed disodium, Alimta®intravenous infusion | Drug | 1, 2 |
Primary outcome
Progression-Free Survival (PFS) in the Overall Population
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Median time (in weeks) from randomization 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-Free Survival in the Female Population
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Median time (in weeks) from randomization 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 RECIST assessment.
8 secondary outcomes
Overall Survival (OS)
Time frame: Time to death in months
Objective Response Rate (ORR)
Time frame: Each participant was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Disease Control Rate (DCR)
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Duration of Response (DoR)
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score
Time frame: LCSS questionnaires are to be administered every 3 weeks after randomization
Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score
Time frame: ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomization
Longitudinal Analysis of Lung Cancer Symptom Scale Total Score
Time frame: LCSS questionnaires are to be administered every 3 weeks after randomization
Longitudinal Analysis of Average Symptom Burden Index Score
Time frame: ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21282537de Boer RH, Arrieta O, Yang CH, Gottfried M, Chan V, Raats J, de Marinis F, Abratt RP, Wolf J, Blackhall FH, Langmuir P, Milenkova T, Read J, Vansteenkiste JF. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2011 Mar 10;29(8):1067-74. doi: 10.1200/JCO.2010.29.5717. Epub 2011 Jan 31.
- 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.
- Related InfoLink provided by the sponsor.
- CSR-D4200C00036.pdfLink provided by the sponsor.
- Vandetanib\_study\_36\_ZEAL\_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.
Clinical Sciences & Operations study director
Sanofi
110 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vandetanib and Pemetrexed in people with Non Small Cell Lung Cancer and Lung Cancer, run by Genzyme, a Sanofi Company at 110 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Argentina, Israel, Spain, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) in the Overall Population (time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00418886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.