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Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Primary Purpose

Non Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Crizotinib

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non small cell lung cancer, NSCLC, ROS1, ROS1 positive, ROS1 proto oncogene, c ros tyrosine kinases, ROS1 positive NSCLC, ROS1 lung cancer, ALK negative, Lung Carcinoma, Neoplasm, Crizotinib, Xalkori, Previously treated or untreated, North East Asian

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
treatment-naïve or have received no more than 3 systemic treatment regimen(s)
Positive for translocation or inversion events involving the ROS1 gene
Negative for translocation or inversion events involving the ALK gene
Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
At least 1 measurable tumor lesion as per RECIST v1.1
Female or male, 18 years of age or older
ECOG performance status 0 to 1
Adequate organ function
Signed and dated informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Exclusion Criteria:

Current treatment on another therapeutic clinical trial
Prior therapy specifically directed against ALK or ROS1 fusion genes
Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
known interstitial fibrosis or interstitial lung disease
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
Pregnant or breast feeding
Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
Evidence of active malignancy within last 3 years

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
The Military General Hospital of Beijing PLA / Medical Oncology Dept.
307 Hospital of PLA/Department of Lung Cancer
Beijing Cancer Hospital, Department of Thoracic Oncology
Chinese PLA General Hospital
Beijing Chest Hospital
Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA
Fujian Province Oncology Hospital
SUN Yat-Sen University Cancer Center
The First Affiliated Hospital of Guangzhou Medical College
Guangdong General Hospital
Hunan Provincial Tumor Hospital/Division of Oncology
Department of Oncology, Jilin Provincial Cancer Hospital
The affiliated hospital of medical college Qingdao University / Medical oncology department
Department of Pulmonary Medicine, Shanghai Chest Hospital
Shanghai Chest Hospital/Lung cancer clinical center
Shanghai Pulmonary Hospital
Zhongshan Hospital Fudan University / Respiratory Department
Oncology Department, West China Hospital of Sichuan University
Sichuan Province Cancer Hospital/Department of Pulmonary Tumor
Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital
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
Zhejiang Cancer Hospital
Shizuoka Cancer Center
Aichi Cancer Center Hospital
National Cancer Center Hospital East
NHO Shikoku Cancer Center
NHO Kyushu Cancer Center
Hyogo Cancer Center
Tohoku University Hospital
Kinki University Hospital
Osaka City General Hospital
Cancer Institute Hospital of JFCR
National Cancer Center Hospital
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
Yonsei University, Severance Hospital
Taichung Veterans General Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crizotinib

Arm Description

Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib

Outcomes

Primary Outcome Measures

Independent Radiology Reviewed Overall Objective Response (ORR)

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 Outcome Measures

IRR-Assessed Duration of Response (DR)

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.

IRR-Assessed Time to Tumor Response (TTR)

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.

IRR Assessed Disease Control Rate (DCR) at 8 Weeks

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.

IRR-Assessed Progression Free Survival (PFS)

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.

Overall Survival (OS)

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.

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

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.

Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4

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.

Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4

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.

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

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).

Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 Scores

The EORTC QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia). Scores on each scale and item ranged from 0 to 100, higher score is indicative of a higher response level (a high score for a symptom scale / item represents a high level of symptomatology / problems).

Full Information

NCT ID

NCT01945021

First Posted

September 5, 2013

Last Updated

February 3, 2021

Sponsor

Pfizer

Collaborators

OxOnc Development LP

1. Study Identification

Unique Protocol Identification Number

NCT01945021

Brief Title

Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Official Title

Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 30, 2013 (Actual)

Primary Completion Date

July 31, 2015 (Actual)

Study Completion Date

January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

OxOnc Development LP

4. Oversight

5. Study Description

Brief Summary

To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation

6. Conditions and Keywords

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

Non Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib

Keywords

Non small cell lung cancer, NSCLC, ROS1, ROS1 positive, ROS1 proto oncogene, c ros tyrosine kinases, ROS1 positive NSCLC, ROS1 lung cancer, ALK negative, Lung Carcinoma, Neoplasm, Crizotinib, Xalkori, Previously treated or untreated, North East Asian

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crizotinib

Arm Type

Experimental

Arm Description

Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib

Intervention Type

Drug

Intervention Name(s)

Crizotinib

Other Intervention Name(s)

Xalkori

Primary Outcome Measure Information:

Title

Independent Radiology Reviewed Overall Objective Response (ORR)

Description

Time Frame

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)

Secondary Outcome Measure Information:

Title

IRR-Assessed Duration of Response (DR)

Description

Time Frame

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)

Title

IRR-Assessed Time to Tumor Response (TTR)

Description

Time Frame

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)

Title

IRR Assessed Disease Control Rate (DCR) at 8 Weeks

Description

Time Frame

At 8 weeks after the start of study treatment

Title

IRR-Assessed Progression Free Survival (PFS)

Description

Time Frame

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)

Title

Overall Survival (OS)

Description

Time Frame

From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks)

Title

Description

Time Frame

Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks)

Title

Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4

Description

Time Frame

Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks)

Title

Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4

Description

Time Frame

Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks)

Title

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

Description

Time Frame

Baseline up to Cycle 60

Title

Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 Scores

Description

Time Frame

Baseline up to Cycle 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic treatment-naïve or have received no more than 3 systemic treatment regimen(s) Positive for translocation or inversion events involving the ROS1 gene Negative for translocation or inversion events involving the ALK gene Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication At least 1 measurable tumor lesion as per RECIST v1.1 Female or male, 18 years of age or older ECOG performance status 0 to 1 Adequate organ function Signed and dated informed consent Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment Exclusion Criteria: Current treatment on another therapeutic clinical trial Prior therapy specifically directed against ALK or ROS1 fusion genes Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease known interstitial fibrosis or interstitial lung disease myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec Pregnant or breast feeding Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list Evidence of active malignancy within last 3 years

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

230022

Country

China

Facility Name

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

City

Chaoyang District

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

The Military General Hospital of Beijing PLA / Medical Oncology Dept.

City

Dongcheng District

State/Province

Beijing

ZIP/Postal Code

100700

Country

China

Facility Name

307 Hospital of PLA/Department of Lung Cancer

City

Fengtai District

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

Beijing Cancer Hospital, Department of Thoracic Oncology

City

Haidian District

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Chinese PLA General Hospital

City

Haidian District

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Beijing Chest Hospital

City

Tongzhou District

State/Province

Beijing

Country

China

Facility Name

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

City

Shapingba District

State/Province

Chongqing

ZIP/Postal Code

400038

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

The First Affiliated Hospital of Guangzhou Medical College

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

Country

China

Facility Name

Hunan Provincial Tumor Hospital/Division of Oncology

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Department of Oncology, Jilin Provincial Cancer Hospital

City

Changchun

State/Province

Jilin

Country

China

Facility Name

The affiliated hospital of medical college Qingdao University / Medical oncology department

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266101

Country

China

Facility Name

Department of Pulmonary Medicine, Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Shanghai Chest Hospital/Lung cancer clinical center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Shanghai Pulmonary Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Zhongshan Hospital Fudan University / Respiratory Department

City

Xuhui District

State/Province

Shanghai

ZIP/Postal Code

200032

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 Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital

City

Hexi District

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

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

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

Country

China

Facility Name

Shizuoka Cancer Center

City

Sunto-gun

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Aichi Cancer Center Hospital

City

Aichi

Country

Japan

Facility Name

National Cancer Center Hospital East

City

Chiba

Country

Japan

Facility Name

NHO Shikoku Cancer Center

City

Ehime

Country

Japan

Facility Name

NHO Kyushu Cancer Center

City

Fukuoka

Country

Japan

Facility Name

Hyogo Cancer Center

City

Hyogo

Country

Japan

Facility Name

Tohoku University Hospital

City

Miyagi

Country

Japan

Facility Name

Kinki University Hospital

City

Osaka

Country

Japan

Facility Name

Osaka City General Hospital

City

Osaka

Country

Japan

Facility Name

Cancer Institute Hospital of JFCR

City

Tokyo

Country

Japan

Facility Name

National Cancer Center Hospital

City

Tokyo

Country

Japan

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Yonsei University, Severance Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

29596029

Citation

Wu YL, Yang JC, Kim DW, Lu S, Zhou J, Seto T, Yang JJ, Yamamoto N, Ahn MJ, Takahashi T, Yamanaka T, Kemner A, Roychowdhury D, Paolini J, Usari T, Wilner KD, Goto K. Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 May 10;36(14):1405-1411. doi: 10.1200/JCO.2017.75.5587. Epub 2018 Mar 29.

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Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

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