Clinical trial NCT05195632: Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer
Official title: Multicenter, Open-label, Phase II Study with a Safety Lead-in Part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAF V600E Mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer Who Are BRAF- and MEK Inhibitor Treatment-naïve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Encorafenib
Binimetinib
Lung Cancer
BRAF-inhibitor
MEK-inhibitor
BRAF V600E -mutated Chinese patients
Non-Small Cell Lung Cancer
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, open-label, phase 2 study.
Primary purpose: TREATMENT

Brief summary: This is a phase 2, multicenter, single-arm study with a safety lead-in to investigate the efficacy, safety and pharmacokinetics of encorafenib 450 mg once daily (QD) in combination with binimetinib 45 mg twice daily (BID) (Combo450) in adult Chinese participants with metastatic unresectable stage IV BRAF V600E mutant NSCLC, who are BRAF- and MEK-inhibitor treatment-naïve and are either previously untreated or have had one line of prior therapy in metastatic setting.


Eligibility criteria: Inclusion Criteria:

If a participant has a BRAF V600E mutational status confirmed as per local assessment, the participant might enter the main screening directly.

All the following inclusion criteria must be met for a participant to be eligible to be included in this study:

1. Provide a signed and dated screening Informed Consent Form (ICF).
2. Chinese male or female with age ≥ 18 years old for China mainland and ≥ 20 years old for Taiwan at the time of the screening informed consent.
3. Documented histology- and/or cytology-confirmed metastatic unresectable Non-small cell lung cancer (NSCLC (i.e. Adenocarcinoma (ADC), large cell carcinoma, squamous cell carcinoma (SCC)).
4. Presence of B-Raf Proto-Oncogene, Serine/Threonine Kinase (BRAF) V600E mutation in tumor tissue previously determined by a local assay at any time prior to screening or by the central laboratory.
5. Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archived or newly obtained) for central prospective laboratory testing of BRAF mutation status and comparison of central BRAF V600E testing in the clinical study to BRAF V600E testing with a candidate companion diagnostic.
6. BRAF- and Mitogen-activated protein kinase kinase (MEK)-inhibitor treatment-naïve participants and previously untreated or have had one line of prior therapy in metastatic setting.
7. At least one measurable disease as per investigator assessment, as defined by RECIST v1.1, which has neither been irradiated nor biopsied during the screening period.
8. Life expectancy ≥ 3 months.
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
10. Adequate hematologic function at screening and baseline.
11. Adequate hepatic function at screening and baseline.
12. Adequate renal function at screening and baseline.
13. Able to comply with the study protocol as per investigator assessment including oral drug intake, complying scheduled visits, treatment plan, laboratory tests and other study procedures.
14. Women are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or child-bearing potential women must agree to take appropriate precautions to avoid pregnancy.
15. Men must agree not to father child until 90 days after the last dose of the study treatment.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible to be included in this study:

1. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs (encorafenib and binimetinib), or their excipients.
2. Documented Anaplastic lymphoma kinase (ALK) fusion oncogene, Reactive oxygen species (ROS) rearrangement or Epidermal growth factor receptor (EGFR) sensitizing or driver mutation.
3. Participants who have received more than one prior line of systemic therapy.
4. Receipt of anti-cancer medications or investigational drugs within the specified intervals before the first administration of study treatment.
5. Symptomatic brain metastases or other active Central nervous system (CNS) metastases.
6. Leptomeningeal disease.
7. Participant has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
8. Current use of prohibited medication ≤ 1 week prior to start of the study treatment and/or concomitantly.
9. Impairment of gastrointestinal function or disease which may significantly alter the absorption of oral study treatment.
10. Impaired cardiovascular function or clinically significant cardiovascular diseases
11. History of thromboembolic or cerebrovascular events within 3 months prior to starting the study treatments
12. History or evidence of retinal pathology considered as risk factor for Retinal vein occlusion (RVO) or neovascular macular degeneration.
13. Concurrent neuromuscular disorder associated with the potential of elevated Creatine phosphokinase (CPK)
14. Participants with active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or any other severe viral active infection (e.g. SARS-CoV-2 infection)
15. Evidence of active, non-infectious pneumonitis, history of interstitial lung disease that required oral or intravenous glucocorticosteroids for management.
16. Known history of a positive test for Human immunodeficiency virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS). Testing for HIV must be performed at sites where mandated locally.
17. Participants who have had major surgery (e.g. inpatient procedure with regional or general anesthesia) within 6 weeks prior to start of study treatment.
18. Participants with concurrent or history of another malignancy within 2 years of study entry Except:

    1. Bowen's disease
    2. Cured basal cell or cutaneous squamous cell carcinoma (CuSCC)
    3. Gleason 6 prostate cancer
    4. Treated in-situ carcinoma of cervix
19. Participant's conditions that contraindicates the use of study treatments and may affect interpretation of results or may render the participant at high risk from treatment complications.
20. Pregnant (confirmed by positive serum beta-human chorionic gonadotropin (ß-HCG) test), lactating or breast-feeding women.
21. Is a family member of the investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician).
22. Is in a position likely to represent a conflict of interest.

Primary outcomes:
measure: Safety Lead-In (SLI) Part: Incidence of Dose-limiting toxicities (DLTs)
timeFrame: Cycle 1; Each cycle is 28 days
measure: Pivotal Part: Confirmed objective response rate (cORR)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days after end of treatment (EOT) visit or 7 days after EOT visit/last dose if EOT not performed), approximately up to 18 months. Each cycle is 28 days.
Secondary outcomes:
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Area under the curve (AUC)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Area under the curve (AUC)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Area under the curve (AUC)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Area under the curve (AUC)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1; Each cycle is 28 days
measure: Safety Lead-In (SLI) Part: Incidence, nature and severity of treatment emergent adverse events (TEAEs)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Hematology
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Chemistry
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Coagulation
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline of dipstick urinalysis
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs from baseline of vital sign examinations.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Safety Lead-In (SLI) Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of echocardiogram or multigated acquisition (ECHO/MUGA) scans.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Confirmed Objective Response Rate (cORR)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Objective Response Rate (ORR)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Duration of Response (DOR)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Disease Control Rate (DCR)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Time to Progression (TTP)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Progression Free Survival (PFS)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Overall Survival (OS)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence, nature and severity of treatment emergent adverse events (TEAEs)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Treatment emergent adverse events (TEAEs) leading to dose interruption, reduction and discontinuation.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent serious adverse events (SAEs)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) leading to death
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Hematology
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Chemistry
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Coagulation
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline of dipstick urinalysis.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs from baseline of vital sign examinations.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs)
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of echocardiogram or multigated acquisition (ECHO/MUGA) scans.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Incidence of targeted treatment emergent adverse events (TEAEs) of special interest.
timeFrame: Cycle 1 Day 1 through safety follow-up visit (30 days (+/- 3 days)) after last study treatment dose or before the initiation of subsequent anticancer therapy, whichever occurs first, approximately up to 18 months. Each cycle is 28 days.
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Area under the curve (AUC)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, and 1, 2, 4, 6 hours post-dose; Cycle 1 to Cycle 6 at pre-dose for sparse samples; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Area under the curve (AUC)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Area under the curve (AUC)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Area under the curve (AUC)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Minimum serum concentration (Cmin)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
measure: Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Maximum serum concentration (Cmax)
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Dalian
country: China
facility: The Second Hospital of Dalian University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian)
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: First Affiliated Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine, Sir Run Run Shaw Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Union Hospital Tongji medical college Huazhong University of Science and Technology
city: Yangzhou
country: China
facility: The Northern Jiangsu People's Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Sun Yat-sen Univ. Cancer Center
name: Li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: