Non-small Cell Lung CanerPhase 2NCT07562581
A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC
A Phase 2 study testing luvometinib + anlotinib in people with Non-small Cell Lung Caner and KRAS-mutated, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Caner, KRAS-mutated, Metastasis
- What is being tested?
- luvometinib + anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 6．At least one intracranial measurable lesion according to RECIST v1.1 criteria.
- 7．Adequate organ function within 7 days before enrollment. 8. 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.
Who cannot join
- 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;
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- 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.
- 4.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.
- 6.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.
- 9.Retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), uncontrolled glaucoma, or other ocular disease interfering with ocular toxicity assessment.
- 10.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.
- 11.Active HBV or HCV; known AIDS or positive HIV; active tuberculosis or syphilis.
- 12.Tumor invasion into major vessels, heart, pericardium, trachea, esophagus, or high risk of esophagotracheal/esophagopleural fistula.
- 13.Significant hemoptysis within 1 month before first dose; clinically significant bleeding, bleeding tendency, coagulopathy, or history of ≥Grade 3 thrombosis.
- 14.Symptomatic or recurrent pleural effusion, ascites, or pericardial effusion requiring frequent drainage.
- 15.Other malignancy diagnosed within 5 years before first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
BAOHUI HAN, +86 13817833343, 18930858216@163.com
Wei Zhang, +86 18017321318, zhwei2002@sjtu.edu.cn
About this study
Official title: 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
Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner
- Conditions
- Non-small Cell Lung Caner, KRAS-mutated, Metastasis, Previous Treamted
- Being tested
- luvometinib + anlotinib
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luvometinib + anlotinibBiological
Also called FCN-159+anlotinib
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.
luvometinib + anlotinibBiological
Also called FCN-159+anlotinib
in this part, patients will receive the combined treatment of luvometinib and anlotinib at the recommended doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: safety run-in part | Experimental | Oral treatment with luvometinib + anlotinib combination, including different doses. Receives: 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. Receives: Biological: luvometinib + anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 24 months
Secondary outcomes (6)
Duration of overall response (DOR)
DOR is defined as the time from the date of the first CR or PR to the first recorded tumor progression or death (death due to any cause), whichever occurs earlier
Measured: up to 24 months
Time to response (TTR)
TTR is defined as the time from the first dose of the investigational drug to the first confirmed CR or PR
Measured: up to 24 months
Disease Control Rate (DCR)
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease(SD)
Measured: up to 24 months
Progress Free Survival (PFS)
PFS is defined as the time from the first dose to the first recorded progressive disease or death from any cause, whichever is first
Measured: up to 24 months
safety of the combination therapy of luvometinib and anlotinib
including the types and frequencies of adverse event (AE) that occurred during the treatment period, Serious adverse events (SAE), adverse events that led to reduction of dose, and adverse events that resulted in discontinuation of dose.
Measured: up to 24 months
PK of the combination therapy of luvometinib and anlotinib
including the types and frequencies of adverse event (AE) that occurred during the treatment period, Serious adverse events (SAE), adverse events that led to reduction of dose, and adverse events that resulted in discontinuation of dose.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CanerStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562581
- Sponsor's protocol ID
- FCN-159-011
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07562581
- Acronym / sponsor ID
- FCN-159-011
- Conditions
- Non-small Cell Lung Caner, KRAS-mutated, Metastasis, Previous Treamted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: safety run-in part | Experimental | Biological: luvometinib + anlotinibOral treatment with luvometinib + anlotinib combination, including different doses. |
| Arm2: expansion part | Experimental | Biological: luvometinib + anlotinibSelect 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 6．At least one intracranial measurable lesion according to RECIST v1.1 criteria.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| luvometinib + anlotinibAlso: FCN-159+anlotinibDose 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. | Biological | Arm1: safety run-in part |
| luvometinib + anlotinibAlso: FCN-159+anlotinibin this part, patients will receive the combined treatment of luvometinib and anlotinib at the recommended doses. | Biological | Arm2: expansion part |
Primary outcome
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)
6 secondary outcomes
Duration of overall response (DOR)
Time frame: up to 24 months
Time to response (TTR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
Progress Free Survival (PFS)
Time frame: up to 24 months
safety of the combination therapy of luvometinib and anlotinib
Time frame: up to 24 months
PK of the combination therapy of luvometinib and anlotinib
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing luvometinib + anlotinib in people with Non-small Cell Lung Caner and KRAS-mutated, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BAOHUI HAN (+86 13817833343, 18930858216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the objective response rate (ORR) per RECIST v1.1 (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.