Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT05195632
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2022-06-02
2026-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm (Safety Lead-in and Pivotal arm)
Encorafenib will be administered as a fixed, flat oral dose of 450 mg QD in combination with binimetinib as a fixed, flat oral dose of 45 mg BID.
Encorafenib
Hard capsule
Binimetinib
Film-coated tablet
Interventions
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Encorafenib
Hard capsule
Binimetinib
Film-coated tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Li Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen Univ. Cancer Center
Locations
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Beijing Cancer Hospital
Beijing, , China
Beijing Chest Hospital, Capital Medical University
Beijing, , China
Peking University First Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
Sichuan Cancer Hospital
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
The Second Hospital of Dalian University
Dalian, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian)
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Hainan General Hospital
Haikou, , China
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Shandong Cancer Hospital
Jinan, , China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, , China
Linyi Cancer Hospital
Linyi, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The First Hospital of China Medical University
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Tianjin Cancer Hospital Airport Hospital
Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Union Hospital Tongji medical college Huazhong University of Science and Technology
Wuhan, , China
The Northern Jiangsu People's Hospital
Yangzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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CTR20212962
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20212961
Identifier Type: REGISTRY
Identifier Source: secondary_id
W00090GE203
Identifier Type: -
Identifier Source: org_study_id
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