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OncoMatch/Clinical Trials/NCT06229340

Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations

Is NCT06229340 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Leflunomide and The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab for ras mutation.

Phase 2RecruitingN.N. Petrov National Medical Research Center of OncologyNCT06229340Data as of Jun 2026Location: Russia

Treatment: Leflunomide · The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumabThere is a huge variety of nucleotide substitutions that activate RAS. The search for new "universal" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies. The use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab

Other

Leflunomide

Cancer type

Colorectal Cancer

Pancreatic Cancer

Non-Small Cell Lung Carcinoma

Small Cell Lung Cancer

Melanoma

Tumor Agnostic

Biomarker criteria

Required: HRAS mutation

Required: KRAS mutation

Required: NRAS mutation

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 85

Prior therapy

Min 2 prior lines

Lab requirements

Blood counts

ANC ≥ 1.5 x 10^9/L (1500/μL); lymphocyte count ≥ 0.5 x 10^9/L (500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without transfusion; hemoglobin ≥ 90 g/L without transfusion

Kidney function

Creatinine clearance ≥ 40 mL/min

Liver function

Serum bilirubin ≤ 1.5 x HGH (≤ 3 x IUH for Gilbert's disease or liver metastases); AST, ALT, and alkaline phosphate ≤ 2.5 x HGN

Cardiac function

left ventricular ejection fraction (LVEF) ≥ 45%

Appropriate hematologic and liver function: ANC ≥ 1.5 x 10^9/L (1500/μL); lymphocyte count ≥ 0.5 x 10^9/L (500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without transfusion; hemoglobin ≥ 90 g/L without transfusion. Creatinine clearance ≥ 40 mL/min. Serum albumin ≥ 25 g/L (2.5 g/dL). Serum bilirubin ≤ 1.5 x HGH, with the following exception: Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH. AST, ALT, and alkaline phosphate ≤ 2.5 x HGN; Exclusion: Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) < 45%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06229340 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require HRAS?

Yes, HRAS mutation is a required biomarker for enrollment.

Does this trial require KRAS?

Yes, KRAS mutation is a required biomarker for enrollment.

Does this trial require NRAS?

Yes, NRAS mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is there an age limit?

Yes. Patients must be 85 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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