NCT06229340 (NТО-RAS) is a Phase 2 clinical trial of Leflunomide in RAS Mutation, sponsored by N.N. Petrov National Medical Research Center of Oncology.

Who is sponsoring NCT06229340?

NCT06229340 is sponsored by N.N. Petrov National Medical Research Center of Oncology.

What drugs are being tested in NCT06229340?

Interventions in NCT06229340: Leflunomide, The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab.

What condition does NCT06229340 study?

NCT06229340 studies RAS Mutation, Ras (Kras or Nras) Gene Mutation, Colorectal Cancer Recurrent, Pancreas Cancer, Lung Cancer, Melanoma, Refractory Cancer.

Is NCT06229340 still recruiting?

NCT06229340 is currently recruiting now. Last updated 29 January 2024.

Last reviewed 2024-01-29 · How we verify

NCT06229340: NТО-RAS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 29 January 2024

What this trial tests

Phase 2 trial testing Leflunomide in RAS Mutation in 20 participants. Currently enrolling.

Timeline

3 October 2023

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	N.N. Petrov National Medical Research Center of Oncology
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	3 October 2023
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	1 location across Russia

Drugs / interventions tested

Leflunomide (LEFLUNOMIDE) — full drug profile →
The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab — full drug profile →

Conditions studied

RAS Mutation — all drugs for RAS Mutation →
Ras (Kras or Nras) Gene Mutation — all drugs for Ras (Kras or Nras) Gene Mutation →
Colorectal Cancer Recurrent — all drugs for Colorectal Cancer Recurrent →
Pancreas Cancer — all drugs for Pancreas Cancer →

Sponsor

N.N. Petrov National Medical Research Center of Oncology — full company profile →

Who can join

Adults 18 to 85, any sex, with RAS Mutation or Ras (Kras or Nras) Gene Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Consensus, debate, and prospective on pancreatic cancer treatments.
Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
Genetics and biology of pancreatic ductal adenocarcinoma.
Ying H, Kimmelman AC, Bardeesy N, Kalluri R, et al · · 2025 · cited 15× · PMID 39510840 · DOI 10.1101/gad.351863.124
Targeting the KRAS Oncogene for Patients with Metastatic Colorectal Cancer.
Miao R, Yu J, Kim RD. · · 2025 · cited 8× · PMID 40361439 · DOI 10.3390/cancers17091512
Oncometabolites in pancreatic cancer: Strategies and its implications.
Maiti A, Mondal S, Choudhury S, Bandopadhyay A, et al · · 2024 · cited 3× · PMID 39713078 · DOI 10.5493/wjem.v14.i4.96005
Melanoma: Pathogenesis and Targeted Therapy.
Fu Y, Liu J, Mo Z, Wang B, et al · · 2026 · PMID 41492362 · DOI 10.1002/mco2.70566
Targeted Therapies and Pharmacologic Advances in Mucous Membrane Pemphigoid: A Comprehensive Review.
Busol VN, Kudryashov NV. · · 2025 · PMID 41236290 · DOI 10.5826/dpc.1504a5749
Autophagy in cancer and protein conformational disorders.
Attanasio S. · · 2025 · PMID 40342093 · DOI 10.1002/1873-3468.70061

Verify or expand the search:

Other trials of Leflunomide

Trials testing the same drug.

NCT06714461 — A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia · active not recruiting
NCT06454383 — Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer · Phase 1 · recruiting
NCT05443425 — Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Tran · Phase 1 · recruiting
NCT05937191 — Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children · Phase 1, PHASE2 · recruiting
NCT05937880 — Leflunomide for Henoch-Schonlein Purpura · NA · recruiting

Other recruiting trials for RAS Mutation

Currently open trials in the same condition.

NCT07252479 — Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations · Phase 1 · recruiting
NCT06321081 — ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC · Phase 2 · recruiting
NCT06218810 — Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS · Phase 2 · recruiting
NCT04776655 — Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB · Phase 3 · recruiting
NCT04678648 — A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies · Phase 1 · recruiting

Other N.N. Petrov National Medical Research Center of Oncology trials

Trials by the same sponsor.

NCT06418789 — High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors · Phase 2 · recruiting
NCT06133699 — Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors · NA · unknown
NCT06043947 — Survival Monitoring in Russian Cancer Registries · active not recruiting
NCT05468827 — ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer · NA · completed
NCT06299852 — Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06229340 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by N.N. Petrov National Medical Research Center of Oncology
Last refreshed: 29 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06229340.

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