Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated… (NCT05195632) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
China63 participantsStarted 2022-06-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs (encorafenib and binimetinib), or their excipients.
What they're measuring
1
Safety Lead-In (SLI) Part: Incidence of Dose-limiting toxicities (DLTs)
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.
✕. 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.