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

Lung Cancer Clinical Trial

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)

Status Suspended

Clinical Trial 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.

Clinical Trial 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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.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. ;

Related Conditions & MeSH terms

• Lung Cancer

• NCT number: NCT05374603
• Study type: Interventional
• Source: AstraZeneca
• Status: Suspended
• Phase: Phase 2
• Start date: November 23, 2022
• Completion date: December 31, 2024