Trial · NCT01154140
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
NCT01154140, Phase 3, Completed, Pfizer; results first posted 2015-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung. Trials, record NCT01154140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
- NCT number
- NCT01154140
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 343 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non Squamous Lung Cancer
- Interventions
- treatment, treatment
- First posted
- 2010-06-30
- Last updated
- 2017-11-06
- Other registries' IDs
- eudract:2010-021336-33
- Results first posted
- 2015-01-05
Source ClinicalTrials.gov
Registered outcomes24
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 | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. |
| Secondary | Overall Survival (OS) | From randomization to death or last date known alive for those not known to have died (up to 72 months) | OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive. |
| Secondary | Overall Survival Probability at Month 12 and 18 | Month 12, 18 | Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target 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 greater than or equal to (\>=) 30% decrease taking as reference the baseline sum of lesion dimensions. 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 clear progression of non-target disease. No new lesions. |
| 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 (up to 35 months) | DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions, disappearance of all non-target lesions. PR: \>=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. |
| Secondary | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 35 months) | TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target 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: \>=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. |
| Secondary | Percentage of Participants With Disease Control at Week 12 Based on IRR | Week 12 | Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with 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: \>=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. |
| Secondary | Time to Progression (TTP) Based on IRR | Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. 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 | Time to Intracranial Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 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. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. |
| Secondary | Time to Extracranial Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 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. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to death or last date known alive for those not known to have died (up to 72 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Overall Survival Probability at Month 12 and 18 | Month 12, 18 | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percent probability | NUMBER |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percentage of participants | 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 (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here Overall number of participants analyzed (N) signifies participants with objective tumor response and were evaluable for this outcome measure. | weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here N signifies participants with objective tumor response and were evaluable for this outcome measure. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control at Week 12 Based on IRR | Week 12 | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) Based on IRR | Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Time to Intracranial Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Time to Extracranial Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 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 24Source ClinicalTrials.gov
See all 24 outcomesResults by group270
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 | Crizotinib | 10.9 | 95% Confidence Interval 8.3 to 13.9 | months | |
| Progression-Free Survival (PFS) Based on IRR | Chemotherapy | 7.0 | 95% Confidence Interval 6.8 to 8.2 | months | |
| Overall Survival (OS) | Crizotinib | NA | 95% Confidence Interval 45.8 to NA | months | |
| Overall Survival (OS) | Chemotherapy | 47.5 | 95% Confidence Interval 32.2 to NA | months | |
| Overall Survival Probability at Month 12 and 18 | Crizotinib | Month 12 | 83.5 | 95% Confidence Interval 77.0 to 88.3 | percent probability |
| Overall Survival Probability at Month 12 and 18 | Chemotherapy | Month 12 | 78.4 | 95% Confidence Interval 71.3 to 83.9 | percent probability |
| Overall Survival Probability at Month 12 and 18 | Crizotinib | Month 18 | 71.5 | 95% Confidence Interval 64.0 to 77.7 | percent probability |
| Overall Survival Probability at Month 12 and 18 | Chemotherapy | Month 18 | 66.6 | 95% Confidence Interval 58.8 to 73.2 | percent probability |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR | Crizotinib | 74.4 | 95% Confidence Interval 67.2 to 80.8 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR | Chemotherapy | 45.0 | 95% Confidence Interval 37.4 to 52.8 | percentage of participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 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 | 172 | |
| Overall Study | STARTED | Chemotherapy | 171 | |
| Overall Study | Treated | Crizotinib | 171 | |
| Overall Study | Treated | Chemotherapy | 169 | |
| Overall Study | COMPLETED | Crizotinib | 81 | |
| Overall Study | COMPLETED | Chemotherapy | 69 | |
| Overall Study | NOT COMPLETED | Crizotinib | 91 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 102 |
Source ClinicalTrials.gov
Adverse events388
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 | 18 | 171 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 53 | 169 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crizotinib | 8 | 171 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 16 | 169 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Crizotinib | 1 | 171 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy | 14 | 169 | |
| other | Bradycardia | Cardiac disorders | Crizotinib | 22 | 171 | |
| other | Bradycardia | Cardiac disorders | Chemotherapy | 0 | 169 | |
| other | Tinnitus | Ear and labyrinth disorders | Crizotinib | 4 | 171 | |
| other | Tinnitus | Ear and labyrinth disorders | Chemotherapy | 10 | 169 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 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 | 169 | 171 |
| Total, other adverse events | Chemotherapy | 164 | 169 |
| Total, serious adverse events | Crizotinib | 71 | 171 |
| Total, serious adverse events | Chemotherapy | 49 | 169 |
Source ClinicalTrials.gov
Papers7
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.
GET https://conductscience.org/api/trials/v1/NCT01154140
GET https://conductscience.org/api/trials/v1/NCT01154140/registered?page=2