Trial · NCT01945021
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
NCT01945021, Phase 2, Completed, Pfizer; results first posted 2016-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC. Trials, record NCT01945021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01945021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
- NCT number
- NCT01945021
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib
- Interventions
- Crizotinib
- First posted
- 2013-09-18
- Last updated
- 2021-02-21
- Results first posted
- 2016-08-01
- Limitations and caveats
Due to small percentage of participants (less than 20%) after Cycle 60, data for EORTC QLQ-C30 score and EORTC QLQ-LC13 score could not be interpreted.~65 participants died during the whole study: 15 participants died within 28 days from last dose of study treatment and were reported as SAEs, while 50 participants died during the survival follow-up.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Independent Radiology Reviewed Overall Objective Response (ORR) | Starting from the first dose study treatment until the first documented CR or PR (every 8 weeks then after 8 cycles at every 12 weeks in duration of 94.0 weeks) | Overall objective response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review \[IRR\]), relative to the total population of response-evaluable participants. Per RECIST v1.1, CR: disappearance of all target lesions. Disappearance of all 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 baseline sum diameters. Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response. |
| Secondary | IRR-Assessed Duration of Response (DR) | From first documentation of objective tumor response to first documentation of objective PD or death due to any cause, whichever occurred first (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | DR: time from first documentation of objective tumor response (CR or PR) to first documentation of objective progressive disease (PD) or to death due to any cause, whichever occurred first. If no progression or death on study was observed, or given antitumor treatment other than study drug, participants were censored on date of last on-study tumor assessment. RECIST v1.1, a) PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study), sum must also demonstrate an absolute increase of \>=5 mm, appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions; b) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); c) PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. |
| Secondary | IRR-Assessed Time to Tumor Response (TTR) | From date of first dose of crizotinib to first documentation of objective response was observed (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | TTR was defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. RECIST v1.1 (as determined by IRR), a) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); b) PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | IRR Assessed Disease Control Rate (DCR) at 8 Weeks | At 8 weeks after the start of study treatment | DCR at 8 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or stable disease (SD) at 8 weeks, respectively, relative to the total population of response evaluable participants. RECIST v1.1 (as determined by IRR), a) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); b) PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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. |
| Secondary | IRR-Assessed Progression Free Survival (PFS) | From the date of first dose of crizotinib until the first documentation of objective PD or death (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | PFS was defined as the time from the date of the first dose of crizotinib to first documentation of objective PD or to death on study due to any cause, whichever occurred first. If no progression or death on study was observed, or given antitumor treatment other than study drug, participants were censored on date of last on-study tumor assessment. RECIST v1.1, PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression. Unequivocal progression of existing non-target lesions. |
| Secondary | Overall Survival (OS) | From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks) | OS was defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | Treatment-emergent AEs :between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to crizotinib was assessed by the investigator. Treatment-related AE: any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE):an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. |
| Secondary | Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | Laboratory values included hemoglobin increased, anemia, platelet count decreased, leukocytosis, white blood cell decreased, lymphocyte count increased, lymphocyte count decreased and neutrophil count decreased. Laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. |
| Secondary | Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | Laboratory values included blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, hypoalbuminemia, hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, hypophosphatemia, Creatinine increased, hyperuricemia, hypermagnesemia, hypomagnesemia, hyperglycemia and hypoglycemia. Laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. |
| Secondary | Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Scores | Baseline up to Cycle 60 | The EORTC QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance/insomnia, constipation, and diarrhea) and the perceived financial burden of treatment. All the scales and single-item scores ranged from 0 to 100, higher score is indicative of a higher response level (high score for a functional scale represents a high / healthy level of functioning; high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Independent Radiology Reviewed Overall Objective Response (ORR) | Starting from the first dose study treatment until the first documented CR or PR (every 8 weeks then after 8 cycles at every 12 weeks in duration of 94.0 weeks) | The response-evaluable population (RES) population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | IRR-Assessed Duration of Response (DR) | From first documentation of objective tumor response to first documentation of objective PD or death due to any cause, whichever occurred first (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. Here, Overall Number of Participants Analyzed signifies number of participants with a confirmed objective response that could have occurred anytime up to 151.3 weeks. | Months | MEDIAN |
| SECONDARY | IRR-Assessed Time to Tumor Response (TTR) | From date of first dose of crizotinib to first documentation of objective response was observed (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. Here, Overall Number of Participants Analyzed signifies number of participants with a confirmed objective response that could have occurred anytime up to 151.3 weeks. | Months | MEDIAN |
| SECONDARY | IRR Assessed Disease Control Rate (DCR) at 8 Weeks | At 8 weeks after the start of study treatment | The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. | Percentage of participants | NUMBER |
| SECONDARY | IRR-Assessed Progression Free Survival (PFS) | From the date of first dose of crizotinib until the first documentation of objective PD or death (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks) | The safety analysis population (SAF) included all enrolled participants who received at least 1 dose of study medication. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least 1 dose of study medication. Here, number analyzed signifies participants evaluable at specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4 | Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks) | SAF included all enrolled participants who received at least one dose of study medication. Here, number analyzed signifies participants evaluable at specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Scores | Baseline up to Cycle 60 | Patient reported outcome (PRO)-evaluable population (PRO) included enrolled participants who received at least 1 dose of study medication and completed the assessments at baseline and with at least 1 post-baseline time point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Independent Radiology Reviewed Overall Objective Response (ORR) | Crizotinib 250 mg | 88 | Participants | ||
| IRR-Assessed Duration of Response (DR) | Crizotinib 250 mg | 19.7 | 95% Confidence Interval 14.1 to NA | Months | |
| IRR-Assessed Time to Tumor Response (TTR) | Crizotinib 250 mg | 1.9 | Full Range 1.6 to 15.8 | Months | |
| IRR Assessed Disease Control Rate (DCR) at 8 Weeks | Crizotinib 250 mg | 88.2 | 95% Confidence Interval 81.3 to 93.2 | Percentage of participants | |
| IRR-Assessed Progression Free Survival (PFS) | Crizotinib 250 mg | 15.9 | 95% Confidence Interval 12.9 to 24.0 | Months | |
| Overall Survival (OS) | Crizotinib 250 mg | 44.2 | 95% Confidence Interval 32.0 to NA | Months | |
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Crizotinib 250 mg | Incidence of All-Causality Adverse Events | 127 | Participants | |
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Crizotinib 250 mg | Incidence of All-Causality Serious Adverse Events | 46 | Participants | |
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Crizotinib 250 mg | Incidence of Treatment Related Adverse Events | 124 | Participants | |
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs | Crizotinib 250 mg | Incidence of Treatment Related Serious Adverse Events | 11 | Participants |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib 250 mg | 127 | |
| Overall Study | Safety Population | Crizotinib 250 mg | 127 | |
| Overall Study | Response Evaluable Population | Crizotinib 250 mg | 127 | |
| Overall Study | Patient Reported Outcome Evaluable | Crizotinib 250 mg | 123 | |
| Overall Study | COMPLETED | Crizotinib 250 mg | 44 | |
| Overall Study | NOT COMPLETED | Crizotinib 250 mg | 83 |
Source ClinicalTrials.gov
Adverse events111
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 | Neutropenia | Blood and lymphatic system disorders | Crizotinib 250 mg | 14 | 127 | |
| other | Anaemia | Blood and lymphatic system disorders | Crizotinib 250 mg | 15 | 127 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crizotinib 250 mg | 8 | 127 | |
| other | Sinus bradycardia | Cardiac disorders | Crizotinib 250 mg | 11 | 127 | |
| other | Vision blurred | Eye disorders | Crizotinib 250 mg | 25 | 127 | |
| other | Visual impairment | Eye disorders | Crizotinib 250 mg | 22 | 127 | |
| other | Diplopia | Eye disorders | Crizotinib 250 mg | 7 | 127 | |
| other | Photopsia | Eye disorders | Crizotinib 250 mg | 7 | 127 | |
| other | Diarrhoea | Gastrointestinal disorders | Crizotinib 250 mg | 62 | 127 | |
| other | Nausea | Gastrointestinal disorders | Crizotinib 250 mg | 58 | 127 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib 250 mg | 65 | 127 |
| Total, other adverse events | Crizotinib 250 mg | 127 | 127 |
| Total, serious adverse events | Crizotinib 250 mg | 46 | 127 |
Source ClinicalTrials.gov
Papers2
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.
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