AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3SANOVONCT05009836

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

A Phase 3 study testing Savolitinib and Osimertinib in people with Non-small Cell Lung Cancer, run by Hutchmed at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Savolitinib and Osimertinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
412 participants
Where
1 siteChina
Study dates
6 Sep 2021to 30 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 12Show fewer
  • 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.

Who cannot join

  • 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;
Show all 23Show fewer
  • 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.
  • Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
  • Lack of compliance with participation in this clinical study or inability to comply with the limitations and requirements of the study, as judged by investigators;
  • Having participated in other drug clinical trials and received the study drug within 3 weeks prior to the start of study treatment;
  • Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
  • Previous history of interstitial lung diseases, drug-induced interstitial lung diseases, radiation pneumonitis requiring glucocorticoid therapy and any active interstitial lung diseases;
  • Pregnant and lactating women;
  • Any other disease, metabolic abnormality, physical examination abnormality or laboratory examination abnormality, certain disease or state, based on which there is a reason to suspect that the subject is not suitable for the study drug, or one condition that will affect intepretaton of the study results or put the subject at high risk.
  • History of cirrhosis of any etiology and clinical stage; or other severe liver disease or chronic disease with severe liver involvement.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong General Hospital

    Guangzhou

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib + Osimertinib Versus Placebo + Osimertinib as the First Line Therapy for Patients With EGFRm+/MET+ NSCLC

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

Read the detailed description

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib Combined with Osimertinib versus Placebo Combined with Osimertinib as the First-line Therapy for Patients with EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Being tested
Savolitinib, Placebo, Osimertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SavolitinibDrug

    Also called HMPL-504

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

  • PlaceboDrug

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

  • OsimertinibDrug

    Osimertinib 80 mg QD orally

Study groups in NCT05009836
Study groupRoleWhat they receive
Savolitinib + OsimertinibExperimentalSavolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally+ Osimertinib 80 mg QD orally ( every 3 weeks)
Receives: Drug: Savolitinib; Drug: Osimertinib
Placebo + OsimertinibPlacebo comparatorPlacebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally+ Osimertinib 80 mg QD orally ( every 3 weeks)
Receives: Drug: Placebo; Drug: Osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

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

    Measured: 17 months after the last patient enrolled

Secondary outcomes (8)

  1. Safety and tolerability

    Incidence and nature of treatment emergent adverse events (TEAE), the other safety variables including physical examination, vital signs and laboratory examinations

    Measured: 17 months after the last patient enrolled

  2. The objective response rate of the tumor (ORR)

    the incidence of confirmed complete response or partial response

    Measured: 17 months after the last patient enrolled

  3. The disease control rate (DCR)

    the incidence of complete response, partial response and stable disease

    Measured: 17 months after the last patient enrolled

  4. Duration of Response (DoR)

    the duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded

    Measured: 17 months after the last patient enrolled

  5. Overall survival (OS)

    the time from the date of randomization to the date of death (all causes)

    Measured: 17 months after the last patient enrolled

  6. PFS

    PFS evaluated by the IRC and investigators in the MET-amplified set

    Measured: 17 months after the last patient enrolled

  7. PFS

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

    Measured: 17 months after the last patient enrolled

  8. Development of diagnostic technology

    The residual samples may be used for development of MET Companion Diagnostics (CDx)

    Measured: 17 months after the last patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start6 Sep 2021
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009836
Sponsor's protocol ID
2020-504-00CH4
Acronym
SANOVO
Status last verified
Sep 2026
First submitted
30 Jul 2021
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Savolitinib and Osimertinib in people with Non-small Cell Lung Cancer, run by Hutchmed at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 17 months after the last patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in