Trial · NCT00364351
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
NCT00364351, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy. Trials, record NCT00364351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00364351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
- NCT number
- NCT00364351
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,574 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Vandetanib, Erlotinib
- First posted
- 2006-08-15
- Last updated
- 2018-01-25
- Other registries' IDs
- eudract:2006-000259-16
- Results first posted
- 2011-05-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | Time to death in months | Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown). |
| Secondary | Objective Response Rate (ORR) | RECIST tumour assessments 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 up to 21 months | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions. |
| Secondary | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression | Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD \>= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation. |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30. Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires). Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires). Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | 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. | Weeks | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Time to death in months | Months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | RECIST tumour assessments 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 up to 21 months | Participants | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression | Participants | NUMBER | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Weeks | MEDIAN | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Weeks | MEDIAN | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Vandetanib | 11.3 | Full Range 0.14 to 75.43 | Weeks | |
| Progression-Free Survival (PFS) | Erlotinib | 8.9 | Full Range 0.43 to 80.43 | Weeks | |
| Overall Survival (OS) | Vandetanib | 6.9 | Full Range 0.03 to 18.46 | Months | |
| Overall Survival (OS) | Erlotinib | 7.8 | Full Range 0.10 to 20.04 | Months | |
| Objective Response Rate (ORR) | Vandetanib | 75 | Participants | ||
| Objective Response Rate (ORR) | Erlotinib | 74 | Participants | ||
| Disease Control Rate (DCR) | Vandetanib | 254 | Participants | ||
| Disease Control Rate (DCR) | Erlotinib | 242 | Participants | ||
| Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain | Vandetanib | 11.1 | Inter-Quartile Range 4.4 to 26 | Weeks | |
| Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain | Erlotinib | 9.9 | Inter-Quartile Range 4.3 to 24.3 | Weeks |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib | 623 | |
| Overall Study | STARTED | Erlotinib | 617 | |
| Overall Study | COMPLETED | Vandetanib | 31 | |
| Overall Study | COMPLETED | Erlotinib | 34 | |
| Overall Study | NOT COMPLETED | Vandetanib | 592 | |
| Overall Study | NOT COMPLETED | Erlotinib | 583 |
Source ClinicalTrials.gov
Adverse events502
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Vandetanib | 58 | 623 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib | 87 | 614 | |
| other | Diarrhoea | Gastrointestinal disorders | Vandetanib | 300 | 623 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib | 232 | 614 | |
| other | Dyspepsia | Gastrointestinal disorders | Vandetanib | 29 | 623 | |
| other | Dyspepsia | Gastrointestinal disorders | Erlotinib | 31 | 614 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib | 138 | 623 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib | 131 | 614 | |
| other | Stomatitis | Gastrointestinal disorders | Vandetanib | 33 | 623 | |
| other | Stomatitis | Gastrointestinal disorders | Erlotinib | 33 | 614 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib | ||
| Total, all-cause mortality | Erlotinib | ||
| Total, other adverse events | Vandetanib | 539 | 623 |
| Total, other adverse events | Erlotinib | 542 | 614 |
| Total, serious adverse events | Vandetanib | 197 | 623 |
| Total, serious adverse events | Erlotinib | 155 | 614 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib vs Erlotinib: Objective Response Rate (ORR) | Trial comparisons |
| Vandetanib vs Erlotinib: Disease Control Rate (DCR) | Trial comparisons |
| Vandetanib vs Erlotinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00364351
GET https://conductscience.org/api/trials/v1/NCT00364351/events?page=2