A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC

NCT07562581 | Not Yet Recruiting Phase 2

• 1 other identifier: FCN-159-011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner

Conditions

KRAS-mutated; Metastasis; Previous Treamted; Non-small Cell Lung Caner

Outcome Measures

Primary Outcomes (1)

• the objective response rate (ORR) per RECIST v1.1

  ORR assessed per RECIST v1.1 criteria,and defined as the proportion of patients with confirmed complete response (CR) and partial response (PR)

  up to 24 months

Secondary Outcomes (6)

• Duration of overall response (DOR)

  up to 24 months

• Time to response (TTR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Progress Free Survival (PFS)

  up to 24 months

• safety of the combination therapy of luvometinib and anlotinib

  up to 24 months

Study Arms (2)

Arm1: safety run-in part

EXPERIMENTAL

Oral treatment with luvometinib + anlotinib combination, including different doses.

Biological: luvometinib + anlotinib

Arm2: expansion part

EXPERIMENTAL

Select the optimal doses of luvometinib + anlotinib combination from the safety run-in period and continue enrolling about 30 patients to evaluate the efficacy and further safety.

Biological: luvometinib + anlotinib

Interventions

luvometinib + anlotinib BIOLOGICAL

Dose A：luvometinib 8mg and anlotinib 8mg; Dose B1：luvometinib 12mg and anlotinib 8mg; Dose B2: luvometinib 8mg and anlotinib 10mg; Dose C: luvometinib 12mg and anlotinib 10mg.

Also known as: FCN-159+anlotinib

Arm1: safety run-in part

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between ≥ 18 years and ≤75 years; regardless of male or female.
• Histologically and/or cytologically confirmed diagnosis of non-small cell lung caner,and the clinical stage is IV(AJCC 4th）; Received at least one line of systemic treatment(including platinum-based chemotherapy ± PD-(L)1) during the stage IV, and disease progression occured during or after the treatment.
• KRAS mutation positive.
• ECOG score 0-1. 5. Expected survival time ≥ 3 months.
• ．At least one intracranial measurable lesion according to RECIST v1.1 criteria.
• \. Avoid excessive exposure to sunlight, and be willing to use sufficient sunscreen when there is expected to be sunlight exposure.
• \. Take contraceptive measures as required.

You may not qualify if:

• ．Patients who have previously received any of the following treatments:
• Prior treatment with MEK inhibitors、anlotinib or other VEGFR-TKI(such as cabozantinib, sorafenib, apatinib,etc);
• Major surgery within 28 days or minor surgery within 14 days prior to the first dose, or need to undergo major surgery during the study treatment;
• Systemic anti-cancer treatment (including chemotherapy, targeted therapy, immunotherapy, and other clinical trial drug treatments) within 28 days prior to the first dose or within 5 drug half-lives (whichever is shorter).
• Treatment with traditional Chinese medicine, Chinese patent medicine or modern Chinese medicine preparations with anti-tumor indications within 7 days prior to the first dose;
• Radical radiotherapy within 28 days prior to the first dose; palliative radiotherapy allowed if ≥14 days before first dose;
• Live or live-attenuated vaccine within 28 days prior to the first dose; other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose;
• History of allogeneic organ transplantation or allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months prior to the first dose.
• ．Active CNS metastases; brainstem, leptomeningeal, spinal cord metastases or spinal cord compression.
• Small cell lung cancer (including mixed SCLC/NSCLC) or cavitary central squamous cell carcinoma.
• Receipt of ≥4 prior lines of systemic anticancer therapy. 5.Active autoimmune disease requiring systemic therapy in the past 2 years,except: stable disease on replacement therapy without systemic treatment; non-systemic dermatologic conditions (vitiligo, psoriasis) or alopecia.
• Active infection requiring systemic therapy within 2 weeks before first dose. 7.Uncontrolled hypertension. 8.Dysphagia, active gastrointestinal disease, malabsorption, or any condition impairing study drug absorption.
• Retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), uncontrolled glaucoma, or other ocular disease interfering with ocular toxicity assessment.
• Current or previous idiopathic pulmonary fibrosis/pneumonitis; active ILD, pneumonitis (including clinically significant radiation pneumonitis), pulmonary fibrosis; history of tracheal fistula; continuous oxygen requirement due to severe dyspnea or respiratory insufficiency.
• Active HBV or HCV; known AIDS or positive HIV; active tuberculosis or syphilis.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

BAOHUI HAN

CONTACT

+86 13817833343; 18930858216@163.com

Wei Zhang

CONTACT

+86 18017321318; zhwei2002@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)