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Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC (SOUND)

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Savolitinib
Durvalumab
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Female or male patients aged 18 years or over

  • NSCLC with the following features:

    1. locally advanced or metastatic NSCLC
    2. EGFR wild-type
    3. MET Exon 14 skipping mutation, or MET overexpression, or MET amplification based on FISH or NGS
    4. Tissue sample / liquid sample available
  • Patients must have measurable disease per RECIST 1.1
  • World Health Organization (WHO) performance status 0 or 1 at enrollment
  • Adequate hematological, liver, renal functions
  • Adequate coagulation parameters
  • A minimum life expectancy of 12 weeks
  • Ability to swallow and retain oral medications.
  • Ability and willingness to comply with the study and follow-up
  • Informed consent Exclusion Criteria
  • History of allogeneic organ transplantation.
  • Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy
  • severe cardiac diseases in 6 months, clinically important abnormalities in QT interval & ECGs
  • Uncontrolled hypertension
  • radiotherapy administered ≤28 days before 1st-dose, or has not recovered from side effects
  • Spinal cord compression or symptomatic brain metastases
  • Hypersensitivity to durvalumab or savolitinib or drugs with a similar chemical structure or class
  • Prior exposure to any immune-mediated therapy or MET inhibitor
  • Active or prior documented autoimmune or inflammatory disorders
  • Major surgical procedures ≤28 days of 1st-dose or minor surgical procedures ≤7 days
  • Serious underlying medical condition, serious active infection, uncontrolled intercurrent illness
  • Active hepatitis B or hepatitis C.
  • Active cancers, or history of treatment for invasive cancer, within the last 5 years
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment
  • Women who are either pregnant or breast-feeding
  • Participation in another clinical study with an investigational product administered in 3 months
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Savolitinib combine with Durvalumab

Arm Description

single-arm

Outcomes

Primary Outcome Measures

PFS
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

ORR
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
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
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
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.

Full Information

First Posted
April 29, 2022
Last Updated
October 2, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05374603
Brief Title
Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC
Acronym
SOUND
Official Title
Savolitinib Combine With Durvalumab in Chinese EGFR Wild-type Locally Advanced or Metastatic NSCLC Patients With MET Alteration: An Open-label, Interventional, Multiple-center, Exploratory Trial (SOUND)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Savolitinib combine with Durvalumab
Arm Type
Experimental
Arm Description
single-arm
Intervention Type
Drug
Intervention Name(s)
Savolitinib
Intervention Description
Savolitinib combine with Durvalumab
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
savolitinib plus durvalumab
Primary Outcome Measure Information:
Title
PFS
Description
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.
Time Frame
The analysis will occur when 60 percent PFS event is observed in each cohort, at approximately 10 months after last patient in.
Secondary Outcome Measure Information:
Title
ORR
Description
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.
Time Frame
The analysis will occur at two months after last patient in.
Title
DoR
Description
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).
Time Frame
The analysis will occur when 60 percent PFS event is observed in each cohort, at approximately 10 months after last patient in.
Title
DCR
Description
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.
Time Frame
The analysis will occur at two months after last patient in.
Title
OS
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Female or male patients aged 18 years or over NSCLC with the following features: locally advanced or metastatic NSCLC EGFR wild-type MET Exon 14 skipping mutation, or MET overexpression, or MET amplification based on FISH or NGS Tissue sample / liquid sample available Patients must have measurable disease per RECIST 1.1 World Health Organization (WHO) performance status 0 or 1 at enrollment Adequate hematological, liver, renal functions Adequate coagulation parameters A minimum life expectancy of 12 weeks Ability to swallow and retain oral medications. Ability and willingness to comply with the study and follow-up Informed consent Exclusion Criteria History of allogeneic organ transplantation. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy severe cardiac diseases in 6 months, clinically important abnormalities in QT interval & ECGs Uncontrolled hypertension radiotherapy administered ≤28 days before 1st-dose, or has not recovered from side effects Spinal cord compression or symptomatic brain metastases Hypersensitivity to durvalumab or savolitinib or drugs with a similar chemical structure or class Prior exposure to any immune-mediated therapy or MET inhibitor Active or prior documented autoimmune or inflammatory disorders Major surgical procedures ≤28 days of 1st-dose or minor surgical procedures ≤7 days Serious underlying medical condition, serious active infection, uncontrolled intercurrent illness Active hepatitis B or hepatitis C. Active cancers, or history of treatment for invasive cancer, within the last 5 years Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment Women who are either pregnant or breast-feeding Participation in another clinical study with an investigational product administered in 3 months Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Lu, Doctor
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
CN-100730
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trails via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrails.pharmacm.com/ST/Submission/Disclosure. Indicates that AZ accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrails.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in approved sponsored tool. Signed Data Sharing Agreement(non-negotiable contract for data accessors)must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MES to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrails.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC

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