NCT07562581
Not yet recruiting
Phase 2
A Multicenter, Open-label, Single-arm Phase 2 Study to Evaluate the Efficacy and Safety of Luvometinib Combined With Anlotinib in Patients With KRAS-mutated Metastatic Non-small Cell Lung Cancer
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.1 site in 1 country48 target enrollmentStarted: June 1, 2026Last updated:
Interventionsluvometinib + anlotinib
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- the objective response rate (ORR) per RECIST v1.1
Overview
Brief Summary
Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •Expected survival time ≥ 3 months.
- •6．At least one intracranial measurable lesion according to RECIST v1.1 criteria.
- •7．Adequate organ function within 7 days before enrollment.
- •Recovery to ≤grade 1 or return to baseline from previous treatment-related adverse events (according to CTCAE 5.0), except for adverse events such as hair loss that are judged by the investigators to be safe and do not violate other inclusion criteria.
- •9\. Avoid excessive exposure to sunlight, and be willing to use sufficient sunscreen when there is expected to be sunlight exposure.
- •10\. Take contraceptive measures as required.
Exclusion Criteria
- •1．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.
- •2．Active CNS metastases; brainstem, leptomeningeal, spinal cord metastases or spinal cord compression.
- •3.Small cell lung cancer (including mixed SCLC/NSCLC) or cavitary central squamous cell carcinoma.
Arms & Interventions
Arm1: safety run-in part
Experimental
Oral treatment with luvometinib + anlotinib combination, including different doses.
Intervention: luvometinib + anlotinib (Biological)
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.
Intervention: luvometinib + anlotinib (Biological)
Outcomes
Primary Outcomes
the objective response rate (ORR) per RECIST v1.1
Time Frame: up to 24 months
ORR assessed per RECIST v1.1 criteria,and defined as the proportion of patients with confirmed complete response (CR) and partial response (PR)
Secondary Outcomes
- 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)
- PK of the combination therapy of luvometinib and anlotinib(up to 24 months)
Investigators
Study Sites (1)
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