Trial · NCT00418886
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients
NCT00418886, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2012-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients. Trials, record NCT00418886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients
- NCT number
- NCT00418886
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 698 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Interventions
- Vandetanib, Pemetrexed
- First posted
- 2007-01-05
- Last updated
- 2024-12-31
- Other registries' IDs
- eudract:2006-003695-35
- Results first posted
- 2012-03-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in the Overall Population | 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. |
| Primary | Progression-Free Survival in the Female Population | 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. |
| Secondary | Overall Survival (OS) | Time to death in months | 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). |
| Secondary | Objective Response Rate (ORR) | 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 | 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. |
| Secondary | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | 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. |
| Secondary | Duration of Response (DoR) | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | 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). |
| Secondary | Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score | LCSS questionnaires are to be administered every 3 weeks after randomization | 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. |
| Secondary | Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score | ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomization | 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. |
| Secondary | Longitudinal Analysis of Lung Cancer Symptom Scale Total Score | LCSS questionnaires are to be administered every 3 weeks after randomization | 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). |
| Secondary | Longitudinal Analysis of Average Symptom Burden Index Score | ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomization | 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). |
Source ClinicalTrials.gov
Outcomes10
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) in the Overall Population | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | The full analysis set included all randomized participants. | weeks | MEDIAN |
| PRIMARY | Progression-Free Survival in the Female Population | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | The female analysis set included all randomized female participants. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time to death in months | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | 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 | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression | The full analysis set included all randomized participants. Only participants with response are analyzed for this outcome measure. | weeks | MEDIAN |
| SECONDARY | Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score | LCSS questionnaires are to be administered every 3 weeks after randomization | The full analysis set included all randomized participants. | weeks | MEDIAN |
| SECONDARY | Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score | ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomization | The full analysis set included all randomized participants. | weeks | MEDIAN |
| SECONDARY | Longitudinal Analysis of Lung Cancer Symptom Scale Total Score | LCSS questionnaires are to be administered every 3 weeks after randomization | The full analysis set included all randomized participants. | mms on a visual analogue scale | LEAST_SQUARES_MEAN |
| SECONDARY | Longitudinal Analysis of Average Symptom Burden Index Score | ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomization | The full analysis set included all randomized participants. | mms on a visual analogue scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
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) in the Overall Population | Vandetanib Plus Pemetrexed | 17.6 | 95% Confidence Interval 13.4 to 18.9 | weeks | |
| Progression-Free Survival (PFS) in the Overall Population | Placebo Plus Pemetrexed | 11.9 | 95% Confidence Interval 11.4 to 15.9 | weeks | |
| Progression-Free Survival in the Female Population | Vandetanib Plus Pemetrexed | 17.9 | 95% Confidence Interval 14.7 to 22.7 | weeks | |
| Progression-Free Survival in the Female Population | Placebo Plus Pemetrexed | 13.0 | 95% Confidence Interval 11.1 to 17.7 | weeks | |
| Overall Survival (OS) | Vandetanib Plus Pemetrexed | 10.5 | 95% Confidence Interval 8.9 to 12.3 | months | |
| Overall Survival (OS) | Placebo Plus Pemetrexed | 9.2 | 95% Confidence Interval 7.1 to 12.0 | months | |
| Objective Response Rate (ORR) | Vandetanib Plus Pemetrexed | 19.1 | percentage of participants | ||
| Objective Response Rate (ORR) | Placebo Plus Pemetrexed | 7.9 | percentage of participants | ||
| Disease Control Rate (DCR) | Vandetanib Plus Pemetrexed | 56.6 | percentage of participants | ||
| Disease Control Rate (DCR) | Placebo Plus Pemetrexed | 45.7 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Period | STARTED | Vandetanib Plus Pemetrexed | 256 | |
| Randomized Period | STARTED | Placebo Plus Pemetrexed | 278 | |
| Randomized Period | Treated | Vandetanib Plus Pemetrexed | 260 | |
| Randomized Period | Treated | Placebo Plus Pemetrexed | 273 | |
| Randomized Period | COMPLETED | Vandetanib Plus Pemetrexed | 30 | |
| Randomized Period | COMPLETED | Placebo Plus Pemetrexed | 23 | |
| Randomized Period | NOT COMPLETED | Vandetanib Plus Pemetrexed | 226 | |
| Randomized Period | NOT COMPLETED | Placebo Plus Pemetrexed | 255 | |
| Survival Follow-up Period | STARTED | Vandetanib Plus Pemetrexed | 120 | |
| Survival Follow-up Period | STARTED | Placebo Plus Pemetrexed | 114 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events680
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 | Anaemia | Blood and lymphatic system disorders | Randomized Period: Vandetanib Plus Pemetrexed | 19 | 260 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | Randomized Period: Placebo Plus Pemetrexed | 54 | 273 | 59 |
| other | Anaemia | Blood and lymphatic system disorders | Survival Follow-up Period: Vandetanib Plus Pemetrexed | 0 | 124 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Survival Follow-up Period: Placebo Plus Pemetrexed | 1 | 110 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Randomized Period: Vandetanib Plus Pemetrexed | 18 | 260 | 27 |
| other | Leukopenia | Blood and lymphatic system disorders | Randomized Period: Placebo Plus Pemetrexed | 17 | 273 | 22 |
| other | Leukopenia | Blood and lymphatic system disorders | Survival Follow-up Period: Vandetanib Plus Pemetrexed | 0 | 124 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Survival Follow-up Period: Placebo Plus Pemetrexed | 0 | 110 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Randomized Period: Vandetanib Plus Pemetrexed | 21 | 260 | 32 |
| other | Neutropenia | Blood and lymphatic system disorders | Randomized Period: Placebo Plus Pemetrexed | 26 | 273 | 35 |
1 to 10 of 680Source ClinicalTrials.gov
See all 680 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Period: Vandetanib Plus Pemetrexed | 122 | 260 |
| Total, all-cause mortality | Randomized Period: Placebo Plus Pemetrexed | 147 | 273 |
| Total, all-cause mortality | Survival Follow-up Period: Vandetanib Plus Pemetrexed | 63 | 124 |
| Total, all-cause mortality | Survival Follow-up Period: Placebo Plus Pemetrexed | 58 | 110 |
| Total, other adverse events | Randomized Period: Vandetanib Plus Pemetrexed | 234 | 260 |
| Total, other adverse events | Randomized Period: Placebo Plus Pemetrexed | 242 | 273 |
| Total, other adverse events | Survival Follow-up Period: Vandetanib Plus Pemetrexed | 22 | 124 |
| Total, other adverse events | Survival Follow-up Period: Placebo Plus Pemetrexed | 19 | 110 |
| Total, serious adverse events | Randomized Period: Vandetanib Plus Pemetrexed | 84 | 260 |
| Total, serious adverse events | Randomized Period: Placebo Plus Pemetrexed | 94 | 273 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00418886
GET https://conductscience.org/api/trials/v1/NCT00418886/events?page=2