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

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab

Criteria

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