Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC
- Registration Number
- NCT05374603
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is an open-label, interventional, multiple-center, exploratory Phase II study sponsored by AstraZeneca Investment(China)Co., LTD. to evaluate the efficacy and safety of Savolitinib combine with Durvalumab in Chinese EGFR wild-type locally advanced or metastatic NSCLC patients with MET alteration.
- Detailed Description
Successfully enrolled, eligible patients will receive treatment of durvalumab (1500 mg, ivgtt, q4w) in combination with savolitinib (600mg for BW≥50kg, 400mg for BW\<50kg, p.o., q.d.) after informed consent signed. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.
Tumor assessment is conducted according to RECIST 1.1. Baseline tumor assessments should include CT/MRI of chest and abdomen (including liver and adrenal glands) and should be performed within 28 days prior to receiving first dose of treatment. Follow-up assessments should be performed every 8 weeks (±7 days) after the start of treatment until 4 month, and then every 12 weeks until objective disease progression as defined by RECIST 1.1 even if a patient discontinues treatment prior to progression (unless they withdraw consent). Patients who have been observed CR or PR firstly will be scheduled for an additional visit to confirm efficacy at 4 weeks (+7 days) after the first assessment result of CR or PR was observed.
Safety information should be visit in siteand will be prospectively collected from informed consent to the end of the follow-up period, defined as 3028 days (± 7 days) after last dose of Savolitinib, or 90 days (± 7 days) after last dose of Durvalumab which comes later.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Savolitinib combine with Durvalumab Durvalumab single-arm Savolitinib combine with Durvalumab Savolitinib single-arm
- Primary Outcome Measures
Name Time Method PFS The analysis will occur when 60 percent PFS event is observed in each cohort, at approximately 10 months after last patient in. PFS (Progression-Free Survival ) will be defined as the time from first dose of study intervention until progression per RECIST 1.1 as assessed by the investigator or death due to any cause prior to progressive disease.
- Secondary Outcome Measures
Name Time Method ORR The analysis will occur at two months after last patient in. ORR(Objective Response Rate) defined as the proportion of participants who achieved a CR (Complete Response) or PR(Partial response) as their best overall response based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator.
DoR The analysis will occur when 60 percent PFS event is observed in each cohort, at approximately 10 months after last patient in. DoR(Duration of Response)is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (ie, date of PFS (Progression-Free Survival ) event or censoring-date of first response+1).
DCR The analysis will occur at two months after last patient in. DCR (Disease Control Rate)is defined as the number(percent)of subjects with at least one visit response of confirmed CR (Complete Response), PR (Partial Response) or SD(Stable Disease), based on based on Investigator assessment according to RECIST 1.1.
OS The analysis will occur when 60 percent PFS event ratio is observed in each cohort, at approximately 10 months after last subject in, up to a maximum of approximately 3 years after first subject in. OS(Overall Survival) is defined as the time from the start of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Trial Locations
- Locations (1)
Research Site
🇨🇳Zhengzhou, China