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)

D5083C00002

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.

2022-11-23

2024-10-31

2024-12-31

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-03-01