Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

NCT05009836 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2020-504-00CH4
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  17 months after the last patient enrolled

Secondary Outcomes (8)

• Safety and tolerability

  17 months after the last patient enrolled

• The objective response rate of the tumor (ORR)

  17 months after the last patient enrolled

• The disease control rate (DCR)

  17 months after the last patient enrolled

• Duration of Response (DoR)

  17 months after the last patient enrolled

• Overall survival (OS)

  17 months after the last patient enrolled

Study Arms (2)

Savolitinib

EXPERIMENTAL

Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally

Drug: Savolitinib

placebo

PLACEBO COMPARATOR

Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally

Drug: Placebo

Interventions

Savolitinib DRUG

Subjects will receive Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Also known as: HMPL-504

Savolitinib

Placebo DRUG

Subjects will receive Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

placebo

Eligibility Criteria

• Age: 28 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully aware of this study and voluntary to sign the informed consent form, and being willing and able to comply with the study procedure;
• Age ≥ 18
• In accordance with the Eighth Edition of TNM Staging of Lung Cancer by the International Association for the Study of Lung Cancer and American Joint Committee on Cancer, and patients with histologically or cytologically confirmed unresectable locally advanced (stage ⅢB/ⅢC), metastatic or recurrent (stage IV) NSCLC who are not suitable for radical concurrent chemoradiotherapy;
• Carrying two common EGFR mutations clearly related with the sensitivity to EGFR-TKI (i.e., exon 19 deletion, and L858R) and c-MET overexpression
• Having measurable lesions (in accordance with RECIST 1.1 criteria);
• ECOG Performance Status score 0 or 1, or Karnofsky score ≥80;
• Survival is expected to exceed 12 weeks;
• No any previous systematic antitumor therapy for advanced/metastatic disease;
• adequate bone marrow reserve or organ function
• Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 6 weeks after discontinuation of the study drug , and agree not to donate ova (oocytes) for reproductive purposes during this period;
• Male patients whose sexual partners are women of childbearing potential must use condoms during sexual intercourse during the study and within 6 months after discontinuation of study drug
• Being able to take or swallow the drug orally.

You may not qualify if:

• Previous treatment with EGFR inhibitors or MET inhibitors;
• Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years;
• Antitumor therapy within 2 weeks prior to the start of study treatment, including hormone therapy, biotherapy, immunotherapy or the traditional Chinese medicine for antitumor indication;
• Having received extensive radiotherapy (including radionuclide therapy, e.g., Sr-89) within 4 weeks prior to the start of study treatment or palliative local radiotherapy within one week prior to the start of study treatment, or the above adverse reactions of radiotherapy did not recover;
• Having received a major surgery within 4 weeks prior to the start of study treatment or a minor surgery (except biopsy, and venous catheterization) within one week prior to the start of study treatment;
• Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment;
• Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment;
• Clinically significant active infection, including but not limited to tuberculosis, human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody);
• Active hepatitis B, or active hepatitis C;
• Acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack;
• Uncontrollable hypertension despite the use of drugs,
• Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm;
• Patients whose known cancerous thrombus or deep vein thrombosis are stable for ≥2 weeks after receiving treatment with low molecular weight heparin (LMWH) or analogues with similar efficacy can be enrolled;
• Any important abnormality in rhythm
• Presence of meningeal metastasis, spinal cord compression or active brain metastasis prior to the start of study treatment.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study plans to enroll 412 patients, among them, there are 92 subjects in Savolitinib/Placebo QD administration; and about 320 subjects in Savolitinib/Placebo BID administration will be randomized in a ratio of 1 to 1 into the study group and the control group. Study group: Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally + Osimertinib 80 mg QD orally Control group: Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally+ Osimertinib 80 mg QD orally

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 18, 2021
• Study Start: September 6, 2021
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)