A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
About this trial
Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
luvometinib + anlotinib
Biological/VaccineDose 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 + anlotinib
Biological/Vaccinein this part, patients will receive the combined treatment of luvometinib and anlotinib at the recommended doses.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Arm1: safety run-in partExperimental treatment 1 intervention
Group B: Arm2: expansion partExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
up to 24 monthsSecondary outcomes
1
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
Time frame
up to 24 months2
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
Time frame
up to 24 months3
Disease Control Rate (DCR)
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease(SD)
Time frame
up to 24 months4
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
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov