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 (OCEANII)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2025
  • participants needed
    55
  • sponsor
    Pierre Fabre Medicament
Updated on 20 September 2022
measurable disease
carcinoma
BRAF
large cell carcinoma
kidney function test
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment Binimetinib, Encorafenib
Clinical Study IdentifierNCT05195632
SponsorPierre Fabre Medicament
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

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
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
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

Exclusion Criteria

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
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
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