New drug cocktail targets rare lung cancer mutation in chinese patients

NCT ID NCT05195632

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tests a combination of two targeted drugs, encorafenib and binimetinib, in Chinese patients with advanced non-small cell lung cancer that has a specific BRAF V600E mutation. The goal is to see if the drugs can shrink tumors and control the disease. About 63 patients who have not had prior BRAF or MEK inhibitor treatment will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: encorafenib and binimetinib combination
What this could lead to: If successful, this could provide a new targeted treatment option for Chinese patients with a specific genetic mutation in advanced lung cancer, potentially shrinking tumors and delaying progression.
What could go wrong: This is a mid-stage trial with only 63 participants, so results may not apply to all patients. Side effects from the drug combination are possible, and the treatment may not work for everyone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

Beijing Cancer Hospital

Beijing, China
Beijing Chest Hospital, Capital Medical University

Beijing, China
Chongqing University Cancer Hospital

Chongqing, China
First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, 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
Guangxi Medical University Affiliated Tumor Hospital

Nanning, China
Hainan General Hospital

Haikou, China
Harbin Medical University Cancer Hospital

Harbin, China
Henan Cancer Hospital

Zhengzhou, China
Liaoning Cancer Hospital & Institute

Shenyang, China
Linyi Cancer Hospital

Linyi, China
Peking University First Hospital

Beijing, China
Peking University Shenzhen Hospital

Shenzhen, China
Shandong Cancer Hospital

Jinan, China
Shanxi Provincial Cancer Hospital

Taiyuan, China
Sichuan Cancer Hospital

Chengdu, China
Sun Yat-sen University Cancer Center

Guangzhou, China
Taipei Veterans General Hospital

Taipei, Taiwan
The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, China
The First Affiliated Hospital of Nanchang University

Nanchang, China
The First Hospital of China Medical University

Shenyang, China
The First Hospital of Jilin University

Changchun, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, China
The Northern Jiangsu People's Hospital

Yangzhou, China
The Second Hospital of Dalian University

Dalian, 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
Xiangya Hospital Central South University

Changsha, China
Yantai Yuhuangding Hospital

Yantai, China
Zhejiang Cancer Hospital

Hangzhou, China
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital

Hangzhou, China

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