Trial · NCT01639001
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
NCT01639001, Phase 3, Completed, Pfizer; results first posted 2017-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients. Trials, record NCT01639001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01639001
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
- NCT number
- NCT01639001
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 207 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Interventions
- Crizotinib, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin
- First posted
- 2012-07-12
- Last updated
- 2020-12-08
- Results first posted
- 2017-03-13
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Based on IRR by Treatment Arm | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months) | PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) 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 | Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months) | Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Secondary | Overall Survival (OS) | From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months). | OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - date of randomization +1)/30.44. For participants who were lost to follow-up or withdrew consent, the OS was censored on the last date that participants were known to be alive. |
| Secondary | Percentage of Participants With Disease Control at 12 Weeks Based on IRR | From randomization to Week 12 | Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Secondary | Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | From randomization to 1 year and from randomization to 18 months | Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log \[-log(1-year survival probability)\] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly. |
| Secondary | Duration of Response (DR) Based on IRR | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death - first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response. |
| Secondary | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 33 months). | TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response. |
| Secondary | Time to Progression (TTP) Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44. |
| Secondary | Intracranial Time to Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. |
| Secondary | Extracranial Time to Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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) Based on IRR by Treatment Arm | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months) | The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months). | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control at 12 Weeks Based on IRR | From randomization to Week 12 | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of participants | NUMBER |
| SECONDARY | Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | From randomization to 1 year and from randomization to 18 months | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Percentage of paricipants | NUMBER |
| SECONDARY | Duration of Response (DR) Based on IRR | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR. | Weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 33 months). | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR. | Weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Intracranial Time to Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
| SECONDARY | Extracranial Time to Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Months | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group292
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) Based on IRR by Treatment Arm | Crizotinib | 11.1 | 95% Confidence Interval 8.3 to 12.6 | Months | |
| Progression-Free Survival (PFS) Based on IRR by Treatment Arm | Chemotherapy | 6.8 | 95% Confidence Interval 5.7 to 7.0 | Months | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Crizotinib | 87.5 | 95% Confidence Interval 79.6 to 93.2 | Percentage of participants | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Chemotherapy | 45.6 | 95% Confidence Interval 35.8 to 55.7 | Percentage of participants | |
| Overall Survival (OS) | Crizotinib | 33.7 | 95% Confidence Interval 26.5 to 42.5 | Months | |
| Overall Survival (OS) | Chemotherapy | 32.9 | 95% Confidence Interval 23.9 to 43.1 | Months | |
| Percentage of Participants With Disease Control at 12 Weeks Based on IRR | Crizotinib | 82.7 | 95% Confidence Interval 74.0 to 89.4 | Percentage of participants | |
| Percentage of Participants With Disease Control at 12 Weeks Based on IRR | Chemotherapy | 73.8 | 95% Confidence Interval 64.2 to 82.0 | Percentage of participants | |
| Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | Crizotinib | Up to 1 year | 79.3 | 95% Confidence Interval 70.0 to 86.0 | Percentage of paricipants |
| Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | Chemotherapy | Up to 1 year | 79.5 | 95% Confidence Interval 70.0 to 86.3 | Percentage of paricipants |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 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 | 104 | |
| Overall Study | STARTED | Chemotherapy | 103 | |
| Overall Study | Treated | Crizotinib | 104 | |
| Overall Study | Treated | Chemotherapy | 101 | |
| Overall Study | COMPLETED | Crizotinib | 29 | |
| Overall Study | COMPLETED | Chemotherapy | 26 | |
| Overall Study | NOT COMPLETED | Crizotinib | 75 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 77 |
Source ClinicalTrials.gov
Adverse events230
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 | 20 | 104 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 49 | 101 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crizotinib | 12 | 104 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 20 | 101 | |
| other | Neutropenia | Blood and lymphatic system disorders | Crizotinib | 21 | 104 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 37 | 101 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Crizotinib | 4 | 104 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy | 10 | 101 | |
| other | Sinus bradycardia | Cardiac disorders | Crizotinib | 13 | 104 | |
| other | Sinus bradycardia | Cardiac disorders | Chemotherapy | 0 | 101 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib | 62 | 104 |
| Total, all-cause mortality | Chemotherapy | 61 | 101 |
| Total, other adverse events | Crizotinib | 103 | 104 |
| Total, other adverse events | Chemotherapy | 100 | 101 |
| Total, serious adverse events | Crizotinib | 46 | 104 |
| Total, serious adverse events | Chemotherapy | 13 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29966800 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Crizotinib vs Chemotherapy: deaths from any cause | Trial comparisons |
| Crizotinib vs Chemotherapy: 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/NCT01639001
GET https://conductscience.org/api/trials/v1/NCT01639001/results?page=2