AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2OCEANIINCT05195632

Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing Encorafenib and Binimetinib in people with Non-Small Cell Lung Cancer, run by Pierre Fabre Medicament at 34 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Encorafenib and Binimetinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
34 sitesin 2 countries
Study dates
2 Jun 2022to 14 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Provide a signed and dated screening Informed Consent Form (ICF).
  • 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.
  • 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)).
  • 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.
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  • 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.
  • 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.
  • 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.
  • Life expectancy ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate hematologic function at screening and baseline.
  • Adequate hepatic function at screening and baseline.
  • Adequate renal function at screening and baseline.
  • 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.
  • 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.
  • Men must agree not to father child until 90 days after the last dose of the study treatment.

Who cannot join

  • Participants meeting any of the following criteria are not eligible to be included in this study:
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs (encorafenib and binimetinib), or their excipients.
  • Documented Anaplastic lymphoma kinase (ALK) fusion oncogene, Reactive oxygen species (ROS) rearrangement or Epidermal growth factor receptor (EGFR) sensitizing or driver mutation.
  • Participants who have received more than one prior line of systemic therapy.
  • Receipt of anti-cancer medications or investigational drugs within the specified intervals before the first administration of study treatment.
  • Symptomatic brain metastases or other active Central nervous system (CNS) metastases.
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  • Leptomeningeal disease.
  • Participant has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
  • Current use of prohibited medication ≤ 1 week prior to start of the study treatment and/or concomitantly.
  • Impairment of gastrointestinal function or disease which may significantly alter the absorption of oral study treatment.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • History of thromboembolic or cerebrovascular events within 3 months prior to starting the study treatments
  • History or evidence of retinal pathology considered as risk factor for Retinal vein occlusion (RVO) or neovascular macular degeneration.
  • Concurrent neuromuscular disorder associated with the potential of elevated Creatine phosphokinase (CPK)
  • 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)
  • Evidence of active, non-infectious pneumonitis, history of interstitial lung disease that required oral or intravenous glucocorticosteroids for management.
  • 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.
  • Participants who have had major surgery (e.g. inpatient procedure with regional or general anesthesia) within 6 weeks prior to start of study treatment.
  • Participants with concurrent or history of another malignancy within 2 years of study entry Except:
  • Bowen's disease
  • Cured basal cell or cutaneous squamous cell carcinoma (CuSCC)
  • Gleason 6 prostate cancer
  • Treated in-situ carcinoma of cervix
  • 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.
  • Pregnant (confirmed by positive serum beta-human chorionic gonadotropin (ß-HCG) test), lactating or breast-feeding women.
  • Is a family member of the investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician).
  • Is in a position likely to represent a conflict of interest.

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

China33 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chest Hospital, Capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • Xiangya Hospital Central South University

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • The Second Hospital of Dalian University

    Dalian

  • Fujian Medical University Union Hospital

    Fuzhou

  • Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province (Fuzhou Pulmonary Hospital of Fujian)

    Fuzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Hainan General Hospital

    Haikou

  • First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Zhejiang University School of Medicine, Sir Run Run Shaw Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Shandong Cancer Hospital

    Jinan

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou

  • Linyi Cancer Hospital

    Linyi

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning

  • Liaoning Cancer Hospital & Institute

    Shenyang

  • The First Hospital of China Medical University

    Shenyang

  • Peking University Shenzhen Hospital

    Shenzhen

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Union Hospital Tongji medical college Huazhong University of Science and Technology

    Wuhan

  • The Northern Jiangsu People's Hospital

    Yangzhou

  • Yantai Yuhuangding Hospital

    Yantai

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

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

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.

Being tested
Encorafenib, Binimetinib
Keywords
Encorafenib, Binimetinib, Lung Cancer, BRAF-inhibitor, MEK-inhibitor, BRAF V600E -mutated Chinese patients, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EncorafenibDrug

    Also called PF-07263896 or W0090 (in Europe), LGX818 (in US), ONO-7702 (in Japan)

    Hard capsule

  • BinimetinibDrug

    Also called W0074 (in Europe), MEK162 (in US), ARRY-438162 (in US), ONO-7703 (in Japan)

    Film-coated tablet

Study groups in NCT05195632
Study groupRoleWhat they receive
Treatment arm (Safety Lead-in and Pivotal arm)ExperimentalEncorafenib 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.
Receives: Drug: Encorafenib; Drug: Binimetinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Lead-In (SLI) Part: Incidence of Dose-limiting toxicities (DLTs)

    Incidence of DLTs experienced during the Cycle 1 (days 1 to 28) after the first dose of study treatment. DLT rate defined as the number of DLT-evaluable participants with DLTs in the first 28 days after first dose of study treatment in the SLI (DLT-evaluation period), divided by the number of DLT-evaluable participants.

    Measured: Cycle 1; Each cycle is 28 days

  2. Pivotal Part: Confirmed objective response rate (cORR)

    cORR defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as determined by Independent Central Review (ICR) of radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Proportion of patients who have achieved a confirmed Best Overall Response (cBOR) of CR or PR as determined by per RECIST v1.1 and corresponding exact two-sided binomial 95% Confidence interval (CI).

    Measured: 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 (51)

  1. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  2. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  3. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib: Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  4. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  5. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  6. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib: Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  7. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  8. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  9. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  10. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  11. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  12. Safety Lead-In (SLI) Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1; Each cycle is 28 days

  13. Safety Lead-In (SLI) Part: Incidence, nature and severity of treatment emergent adverse events (TEAEs)

    Incidence, nature and severity of TEAEs graded as per NCI CTCAE v4.03, TEAEs leading to dose interruption, reduction and discontinuation, Treatment-emergent serious adverse events (SAEs), TEAEs leading to death.

    Measured: 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.

  14. Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Hematology

    Hemoglobin, hematocrit, Red Blood Cells (RBC), White Blood Cells (WBC) with differential (absolutes values), platelet counts, neutrophils, lymphocytes, monocytes, basophils and eosinophils

    Measured: 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.

  15. Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Chemistry

    Albumin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and direct bilirubin, gamma glutamyl transferase (GGT), urea or blood urea nitrogen (BUN), creatinine, sodium, potassium, calcium, phosphate, chloride, uric acid, magnesium, Creatinine kinase (CK) (if total CK ≥ 3X upper limit of normal (ULN), then measure isoenzymes including Creatine Kinase BB, Creatine Kinase MB, Creatine Kinase MM), serum creatinine and myoglobin in blood and urinalysis test weekly; if there is no local capability to measure CK isoenzymes, then participants must be referred to a local hospital for appropriate management while central laboratory results are awaited. If a diagnosis of rhabdomyolysis is confirmed, then sites should liaise with their local hospitals regarding management of the participants and administration of study medication), total protein, glucose, lactate dehydrogenase (LDH), lipase and amylase.

    Measured: 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.

  16. Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Coagulation

    Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT)

    Measured: 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.

  17. Safety Lead-In (SLI) Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline of dipstick urinalysis

    Dipstick measurements for specific gravity, pH, protein, glucose, bilirubin, ketones, leukocytes, and blood will be performed. Any clinically significant findings on dipstick will be followed up with a microscopic evaluation.

    Measured: 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.

  18. 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.

    Clinically notable elevated values: Systolic blood pressure (BP): ≥ 160 mmHg and an increase ≥ 20 mmHg from baseline; Diastolic BP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; Heart rate: ≥ 120 beats/min (bpm) with increase from baseline of ≥ 15 bpm; Weight (kg) increase from baseline of ≥ 10%; Body temperature [°C] ≥ 37.5°C). Clinically notable low values: Systolic BP: ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg; Diastolic BP: ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg; Heart rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm; Weight: ≥ 20% decrease from baseline; Body temperature [°C]: ≤ 36 °C. Number of participants with TEAEs related to notable changes to the vital signs after the start of study drug will be reported.

    Measured: 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.

  19. 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)

    12-lead ECGs will be obtained using an internationally recognized 12-lead cardiograph. Clinically notable ECG values: QT [millisecond (ms)] and QT interval (ms) corrected for heart rate using Fridericia's formula (QTcF) intervals (ms): increase from baseline > 30 ms; increase from baseline > 60 ms, new > 450 ms, new > 480 ms, new > 500 ms. Heart rate (beats/min): increase from baseline > 25% to a value > 100 bpm, decrease from baseline > 25% and to a value < 50 bpm. Number of participants with TEAEs related to abnormal or notable changes to ECG parameters after the start of study drug will be reported.

    Measured: 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.

  20. 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.

    ECHO/MUGA scan assess Left Ventricular Ejection Fraction (LVEF). Changes from baseline of LVEF measurements over time will be reported.

    Measured: 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.

  21. Pivotal Part: Confirmed Objective Response Rate (cORR)

    cORR as determined by investigator review of the radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: 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.

  22. Pivotal Part: Objective Response Rate (ORR)

    ORR as determined by investigator review and independent central review (ICR) of the radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: 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.

  23. Pivotal Part: Duration of Response (DOR)

    DOR defined as the time from first documented response (i.e. complete response (CR) or partial response (PR)) to the earliest documented disease progression, as determined by investigator review and independent central review (ICR) of radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first.

    Measured: 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.

  24. Pivotal Part: Disease Control Rate (DCR)

    DCR defined as the proportion of participants who have achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) as determined by investigator review and independent central review (ICR) of radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: 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.

  25. Pivotal Part: Time to Progression (TTP)

    TTP defined as the time from first study treatment dose to the earliest documented disease progression as per investigator review and independent central review (ICR) of radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: 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.

  26. Pivotal Part: Progression Free Survival (PFS)

    PFS defined as the time from first study treatment dose to the earliest documented disease progression as per investigator review and independent central review (ICR) of radiographic disease assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first.

    Measured: 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.

  27. Pivotal Part: Overall Survival (OS)

    OS defined as the time from first study treatment dose to the date of death due to any cause.

    Measured: 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.

  28. Pivotal Part: Incidence, nature and severity of treatment emergent adverse events (TEAEs)

    Incidence, nature and severity of treatment emergent adverse events (TEAEs) graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

    Measured: 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.

  29. Pivotal Part: Treatment emergent adverse events (TEAEs) leading to dose interruption, reduction and discontinuation.

    Incidence, nature and severity of TEAEs leading to dose interruption, reduction and discontinuation will be reported.

    Measured: 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.

  30. Pivotal Part: Incidence of treatment emergent serious adverse events (SAEs)

    Incidence, nature and severity of SAE will be recorded and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

    Measured: 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.

  31. Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) leading to death

    TEAEs leading to deaths will be reported.

    Measured: 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.

  32. Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Hematology

    Hemoglobin, hematocrit, Red Blood Cells (RBC), White Blood Cells (WBC) with differential (absolutes values), platelet counts, neutrophils, lymphocytes, monocytes, basophil and eosinophils

    Measured: 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.

  33. Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Chemistry

    Albumin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and direct bilirubin, gamma glutamyl transferase (GGT), urea or blood urea nitrogen (BUN), creatinine, sodium, potassium, calcium, phosphate, chloride, uric acid, magnesium, Creatinine kinase (CK) (if total CK ≥ 3X upper limit of normal (ULN), then measure isoenzymes (including all fractions), serum creatinine and myoglobin in blood and urinalysis test weekly; if there is no local capability to measure CK isoenzymes, then subjects must be referred to a local hospital for appropriate management while central laboratory results are awaited. If a diagnosis of rhabdomyolysis is confirmed, then sites should liaise with their local hospitals regarding management of the subjects and administration of study medication), total protein, glucose, lactate dehydrogenase (LDH), lipase and amylase.

    Measured: 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.

  34. Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline clinical laboratory parameter: Coagulation

    Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT)

    Measured: 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.

  35. Pivotal Part: Incidence of treatment emergent adverse events (TEAEs) related to notable change from baseline of dipstick urinalysis.

    Dipstick measurements for specific gravity, pH, protein, glucose, bilirubin, ketones, leukocytes, and blood will be performed. Any clinically significant findings on dipstick will be followed up with a microscopic evaluation.

    Measured: 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.

  36. Pivotal Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs from baseline of vital sign examinations.

    Clinically notable elevated values: Systolic blood pressure (BP): ≥ 160 mmHg and an increase ≥ 20 mmHg from baseline; Diastolic BP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; Heart rate: ≥ 120 beats/min (bpm) with increase from baseline of ≥ 15 bpm; Weight (kg) increase from baseline of ≥ 10%; Body temperature [°C] ≥ 37.5°C). Clinically notable low values: Systolic BP: ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg; Diastolic BP: ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg; Heart rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm; Weight: ≥ 20% decrease from baseline; Body temperature [°C]: ≤ 36 °C. Number of participants with TEAEs related to notable changes to the vital signs after the start of study drug will be reported.

    Measured: 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.

  37. Pivotal Part: Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs)

    12-lead ECGs will be obtained using an internationally recognized 12-lead cardiograph. Clinically notable ECG values: QT [millisecond (ms)] and QT interval (ms) corrected for heart rate using Fridericia's formula (QTcF) intervals (ms): increase from baseline > 30 ms; increase from baseline > 60 ms, new > 450 ms, new > 480 ms, new > 500 ms. Heart rate (beats/min): increase from baseline > 25% to a value > 100 bpm, decrease from baseline > 25% and to a value < 50 bpm. Number of participants with TEAEs related to abnormal or notable changes to ECG parameters after the start of study drug will be reported.

    Measured: 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.

  38. 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.

    ECHO/MUGA scan assess Left Ventricular Ejection Fraction (LVEF). Changes from baseline of LVEF measurements over time will be reported.

    Measured: 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.

  39. Pivotal Part: Incidence of targeted treatment emergent adverse events (TEAEs) of special interest.

    Number and percentage of participants with at least one event of adverse event (AE) of special interest (AESI) will be reported.

    Measured: 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.

  40. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: 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

  41. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  42. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib: Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  43. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  44. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  45. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib: Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  46. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  47. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  48. Pivotal Part: Pharmacokinetic (PK) parameter of encorafenib metabolite (LHY746): Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  49. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Area under the curve (AUC)

    Area under the curve (AUC) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  50. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Minimum serum concentration (Cmin)

    Minimum serum concentration (Cmin) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

  51. Pivotal Part: Pharmacokinetic (PK) parameter of binimetinib metabolite (AR00426032): Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) will be calculated and reported.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1; Cycle 1 to Cycle 6 at pre-dose; Each cycle is 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start2 Jun 2022
  3. Primary completion27 May 2024
  4. Study completion14 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, open-label, phase 2 study.
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195632
Sponsor's protocol ID
W00090GE203
Other IDs
CTR20212962, CTR20212961
Acronym
OCEANII
Status last verified
Apr 2026
First submitted
4 Jan 2022
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou H, Zhou Q, Guo Q, Guo W, Chen G, Liu Z, Fan Y, Li Y, Chen YM, Bouras K, Frari LD, Guo A, Klauck I, Sansas B, Zhang L. A phase 2 study of encorafenib in combination with binimetinib for Chinese participants with BRAFV600E mutated metastatic non-small cell lung cancer: Results from the OCEAN II study. Lung Cancer. 2026 Aug 13;220:109580. doi: 10.1016/j.lungcan.2026.109580. Online ahead of print.

    PubMed 42612509

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Encorafenib and Binimetinib in people with Non-Small Cell Lung Cancer, run by Pierre Fabre Medicament at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Lead-In (SLI) Part: Incidence of Dose-limiting toxicities (DLTs) (time frame: Cycle 1; Each cycle is 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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