Trial · NCT00932893
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932893, Phase 3, Completed, Pfizer; results first posted 2013-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene. Trials, record NCT00932893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00932893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
- NCT number
- NCT00932893
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 347 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- PF-02341066, Pemetrexed, Docetaxel
- First posted
- 2009-07-03
- Last updated
- 2017-01-02
- Other registries' IDs
- eudract:2009-012595-27
- Results first posted
- 2013-06-06
- Limitations and caveats
No analyses of ALK fusion variants or protein expression were done due to limited slide stability of unstained tissue sections required for immunohistochemistry and no nucleic acid based assay was available to identify specific ALK gene fusion.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Overall Survival (OS) | Randomization until death (up to 4.5 years) | OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. |
| Secondary | Overall Survival Probability at Months 6 and 12 | Month 6, 12 | Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Objective Response (OR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review. |
| Secondary | Percentage of Participants With Disease Control at Week 6 | Week 6 | Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review. |
| Secondary | Percentage of Participants With Disease Control at Week 12 | Week 12 | Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Duration of Response (DR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Secondary | Time to Tumor Response (TTR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
| Secondary | Plasma Concentration of Crizotinib | Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5 | Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis. |
| Secondary | Number of Participants With Categorical Maximum QTcF for Crizotinib | Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2 | QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to \<480 msec, 480 msec to \<500 msec, and more than or equal to (\>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) | Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | Full analysis set (FAS) included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization until death (up to 4.5 years) | FAS included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Overall Survival Probability at Months 6 and 12 | Month 6, 12 | FAS included all participants who were randomized to study treatment. | percent chance of survival | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control at Week 6 | Week 6 | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control at Week 12 | Week 12 | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response. | weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response. | weeks | MEDIAN |
| SECONDARY | Plasma Concentration of Crizotinib | Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5 | Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Categorical Maximum QTcF for Crizotinib | Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2 | ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group2,006
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) | Crizotinib | 7.7 | 95% Confidence Interval 6.0 to 8.8 | months | |
| Progression-Free Survival (PFS) | Chemotherapy | 3.0 | 95% Confidence Interval 2.6 to 4.3 | months | |
| Overall Survival (OS) | Crizotinib | 21.7 | 95% Confidence Interval 18.9 to 30.5 | months | |
| Overall Survival (OS) | Chemotherapy | 21.9 | 95% Confidence Interval 16.8 to 26.0 | months | |
| Overall Survival Probability at Months 6 and 12 | Crizotinib | Month 6 | 86.6 | 95% Confidence Interval 80.5 to 90.9 | percent chance of survival |
| Overall Survival Probability at Months 6 and 12 | Chemotherapy | Month 6 | 83.8 | 95% Confidence Interval 77.4 to 88.5 | percent chance of survival |
| Overall Survival Probability at Months 6 and 12 | Crizotinib | Month 12 | 70.4 | 95% Confidence Interval 62.9 to 76.7 | percent chance of survival |
| Overall Survival Probability at Months 6 and 12 | Chemotherapy | Month 12 | 66.7 | 95% Confidence Interval 59.1 to 73.2 | percent chance of survival |
| Percentage of Participants With Objective Response (OR) | Crizotinib | 65.3 | 95% Confidence Interval 57.7 to 72.4 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Chemotherapy | 19.5 | 95% Confidence Interval 13.9 to 26.2 | percentage of participants |
1 to 10 of 2,006Source ClinicalTrials.gov
See all 2,006 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib | 173 | |
| Overall Study | STARTED | Chemotherapy | 174 | |
| Overall Study | Treated | Crizotinib | 172 | |
| Overall Study | Treated | Chemotherapy | 171 | |
| Overall Study | COMPLETED | Crizotinib | 40 | |
| Overall Study | COMPLETED | Chemotherapy | 4 | |
| Overall Study | NOT COMPLETED | Crizotinib | 133 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 170 |
Source ClinicalTrials.gov
Adverse events334
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 | Crizotinib | 36 | 172 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 27 | 171 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crizotinib | 24 | 172 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 9 | 171 | |
| other | Photopsia | Eye disorders | Crizotinib | 21 | 172 | |
| other | Photopsia | Eye disorders | Chemotherapy | 1 | 171 | |
| other | Vision blurred | Eye disorders | Crizotinib | 13 | 172 | |
| other | Vision blurred | Eye disorders | Chemotherapy | 5 | 171 | |
| other | Visual impairment | Eye disorders | Crizotinib | 74 | 172 | |
| other | Visual impairment | Eye disorders | Chemotherapy | 8 | 171 |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib | ||
| Total, all-cause mortality | Chemotherapy | ||
| Total, other adverse events | Crizotinib | 172 | 172 |
| Total, other adverse events | Chemotherapy | 169 | 171 |
| Total, serious adverse events | Crizotinib | 80 | 172 |
| Total, serious adverse events | Chemotherapy | 42 | 171 |
Source ClinicalTrials.gov
Papers8
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Crizotinib vs Chemotherapy: serious adverse events |
Source 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.
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