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A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

Primary Purpose

NSCLC (Non-small Cell Lung Cancer)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Crizotinib

Pemetrexed/Cisplatin

Pemetrexed/Carboplatin

About this trial

This is an interventional treatment trial for NSCLC (Non-small Cell Lung Cancer) focused on measuring Crizotinib, ALK positive, ALK, Anaplastic Lymphoma Kinase, NSCLC, Non-Small Cell Lung Cancer, Frontline, 1L, Previously Untreated, East Asian, Non-Squamous

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung.
Positive for translocation or inversion events involving the ALK gene locus.
No prior systemic treatment for locally advanced or metastatic disease. Patients with brain metastases only if treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria
Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.

Exclusion Criteria:

Current treatment on another therapeutic clinical trial.
Prior therapy directly targeting ALK.
Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted.
Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
Pregnancy or breastfeeding.
Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices.
Known HIV infection
History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Sites / Locations

The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Dept. of Respiration. Peking Union Medical College Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Beijing Chest Hospital, Capital Medical University
Oncology Department, the Second Affiliated Hospital of Third Military Medical University,PLA
Oncology Department, XinQiao Hospital of Third Military Medical University,
Fujian Province Oncology Hospital
SUN Yat-Sen University Cancer Center
Guangdong General Hospital, Oncology Center
The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery
Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
Hunan Provincial Tumor Hospital/Division of Oncology
Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine
Department of Oncology, Jilin Provincial Cancer Hospital
The first hospital of China Medical University/Oncology Department
Oncology Department, West China Hospital of Sichuan University
Sichuan Province Cancer Hospital/Department of Pulmonary Tumor
Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
307 Hospital of PLA/Department of Lung Cancer
Beijing Cancer Hospital
The Military General Hospital of Beijing PLA
Peking Union Medical College Hospital
Chinese PLA General Hospital
Beijing Chest Hospital, Capital Medical University
Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA
Shanghai Chest Hospital/Lung cancer clinical center
Shanghai Chest Hospital
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai First People's Hospital
Tianjin Medical University Cancer Institute and Hospital
Pamela Youde Nethersole Eastern Hospital
Queen Mary Hospital
Queen Mary Hospital
Prince of Wales Hospital
Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia
Hospital Pulau Pinang
Chi Mei Medical Center Liouying
Chung Shan Medical University Hospital
Chi Mei Medical Center Liuying
Taipei Veterans General Hospital, Chest Department
Chang Gung Medical Foundation, LinKou Branch
Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crizotinib

Chemotherapy

Arm Description

Crizotinib

Chemotherapy [Option at Investigator's Choice]

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Based on IRR by Treatment Arm

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 Outcome Measures

Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR

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.

Overall Survival (OS)

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.

Percentage of Participants With Disease Control at 12 Weeks Based on IRR

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.

Estimate of the Percentage of Participants Surviving at 1 Year and at 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.

Duration of Response (DR) Based on IRR

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.

Time to Tumor Response (TTR) Based on IRR

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.

Time to Progression (TTP) Based on IRR

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.

Intracranial Time to Progression (IC-TTP) Based on IRR

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.

Extracranial Time to Progression (EC-TTP) Based on IRR

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.

Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough Assessed Using Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13)

The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Coughing, Dyspnoea and Pain in chest each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. TTD in pain in chest, dyspnea, or cough from the QLQ-LC13 was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms.

Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life.

Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dyspnea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.

Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.

Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)-Visual Analog Scale (VAS)

EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Change From Baseline in General Health Status as Assessed by EQ-5D-Index

EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK)

VSAQ-ALK is a self-report measure that was developed to assess the problems of visual disturbances and symptoms may include the appearance of overlapping shadows and after images; shimmering, flashing or trailing lights; strings, streamers, or floaters; as well as hazy or blurry vision. The participants answered "Yes" to the first question (Q1) of VSAQ-ALK "Have you experienced any visual disturbances?" were considered to have experienced visual disturbance and were instructed to complete the rest of the questionnaire. The percentage of participants who responded to Q1 of VSAQ-ALK as "Yes" and as "No" during each study cycle was calculated as (n/N*)*100 where N* was the number of participants who had completed Q1.

Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable

Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results.

Percentage of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)

An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE.

Percentage of Participants With Treatment-Emergent AEs (Treatment Related)

Full Information

NCT ID

NCT01639001

First Posted

July 10, 2012

Last Updated

November 16, 2020

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01639001

Brief Title

A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

Official Title

PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 29, 2012 (Actual)

Primary Completion Date

June 30, 2015 (Actual)

Study Completion Date

January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC (Non-small Cell Lung Cancer)

Keywords

Crizotinib, ALK positive, ALK, Anaplastic Lymphoma Kinase, NSCLC, Non-Small Cell Lung Cancer, Frontline, 1L, Previously Untreated, East Asian, Non-Squamous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crizotinib

Arm Type

Experimental

Arm Description

Crizotinib

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Chemotherapy [Option at Investigator's Choice]

Intervention Type

Drug

Intervention Name(s)

Crizotinib

Intervention Description

250 mg two times daily [BID], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed/Cisplatin

Intervention Description

Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed/Carboplatin

Intervention Description

Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles.

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) Based on IRR by Treatment Arm

Description

Time Frame

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)

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR

Description

Time Frame

Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months)

Title

Overall Survival (OS)

Description

Time Frame

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).

Title

Percentage of Participants With Disease Control at 12 Weeks Based on IRR

Description

Time Frame

From randomization to Week 12

Title

Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months

Description

Time Frame

From randomization to 1 year and from randomization to 18 months

Title

Duration of Response (DR) Based on IRR

Description

Time Frame

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)

Title

Time to Tumor Response (TTR) Based on IRR

Description

Time Frame

Randomization to first documentation of objective tumor response (up to 33 months).

Title

Time to Progression (TTP) Based on IRR

Description

Time Frame

Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months)

Title

Intracranial Time to Progression (IC-TTP) Based on IRR

Description

Time Frame

Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months)

Title

Extracranial Time to Progression (EC-TTP) Based on IRR

Description

Time Frame

Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months)

Title

Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough Assessed Using Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13)

Description

Time Frame

From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months）

Title

Description

Time Frame

Title

Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30

Description

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dyspnea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.

Time Frame

Title

Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

Description

The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.

Time Frame

Title

Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)-Visual Analog Scale (VAS)

Description

Time Frame

Title

Change From Baseline in General Health Status as Assessed by EQ-5D-Index

Description

EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

Time Frame

Title

Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK)

Description

Time Frame

Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to Cycle 86)

Title

Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable

Description

Time Frame

During the screening (less than or equal to 28 days prior to dosing)

Title

Percentage of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)

Description

Time Frame

From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks)

Title

Percentage of Participants With Treatment-Emergent AEs (Treatment Related)

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung. Positive for translocation or inversion events involving the ALK gene locus. No prior systemic treatment for locally advanced or metastatic disease. Patients with brain metastases only if treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures. Exclusion Criteria: Current treatment on another therapeutic clinical trial. Prior therapy directly targeting ALK. Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted. Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec. Pregnancy or breastfeeding. Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices. Known HIV infection History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis. Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230002

Country

China

Facility Name

Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Dept. of Respiration. Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Beijing Chest Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

101149

Country

China

Facility Name

Oncology Department, the Second Affiliated Hospital of Third Military Medical University,PLA

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Oncology Department, XinQiao Hospital of Third Military Medical University,

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Fujian Province Oncology Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350014

Country

China

Facility Name

SUN Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Guangdong General Hospital, Oncology Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Hunan Provincial Tumor Hospital/Division of Oncology

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Facility Name

Department of Oncology, Jilin Provincial Cancer Hospital

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130012

Country

China

Facility Name

The first hospital of China Medical University/Oncology Department

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Facility Name

Oncology Department, West China Hospital of Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Sichuan Province Cancer Hospital/Department of Pulmonary Tumor

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

Facility Name

307 Hospital of PLA/Department of Lung Cancer

City

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

The Military General Hospital of Beijing PLA

City

Beijing

ZIP/Postal Code

100700

Country

China

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Chinese PLA General Hospital

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Beijing Chest Hospital, Capital Medical University

City

Beijing

ZIP/Postal Code

101149

Country

China

Facility Name

Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

Shanghai Chest Hospital/Lung cancer clinical center

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Shanghai Chest Hospital

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Zhongshan Hospital Fudan University / Respiratory Department

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Pamela Youde Nethersole Eastern Hospital

City

Chai Wan

ZIP/Postal Code

Country

Hong Kong

Facility Name

Queen Mary Hospital

City

Hong Kong

ZIP/Postal Code

Country

Hong Kong

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Prince of Wales Hospital

City

Shatin

Country

Hong Kong

Facility Name

Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia

City

Kubang Kerian, Kota Bahru

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Hospital Pulau Pinang

City

Georgetown

State/Province

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Chi Mei Medical Center Liouying

City

Liou Ying Township

State/Province

Tainan

ZIP/Postal Code

736

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Chi Mei Medical Center Liuying

City

Tainan city

ZIP/Postal Code

736

Country

Taiwan

Facility Name

Taipei Veterans General Hospital, Chest Department

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Medical Foundation, LinKou Branch

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University

City

Pathumwan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

29966800

Citation

Wu YL, Lu S, Lu Y, Zhou J, Shi YK, Sriuranpong V, Ho JCM, Ong CK, Tsai CM, Chung CH, Wilner KD, Tang Y, Masters ET, Selaru P, Mok TS. Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus Chemotherapy in East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Oct;13(10):1539-1548. doi: 10.1016/j.jtho.2018.06.012. Epub 2018 Aug 14.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081029&StudyName=A%20Study%20Of%20Crizotinib%20Versus%20Chemotherapy%20In%20Previously%20Untreated%20ALK%20Positive%20East%20Asian%20Non-Small%20Cell%20Lung%20Cancer%20Patients

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

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