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AzTrials

Non-small Cell Lung CancerPhase 3SACHINCT05015608

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

A Phase 3 study testing Savolitinib + Osimertinib and Pemetrexed + Cisplatin /Carboplatin in people with Non-small Cell Lung Cancer, run by Hutchison Medipharma Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Savolitinib + Osimertinib and Pemetrexed + Cisplatin /Carboplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
22 Nov 2021to 22 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure;
  • Age ≥ 18 and ≤75 years;
  • In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung Cancer and American Joint Committee on Cancer, patients with histologically or cytologically confirmed unresectable and non-suitable for radical concurrent chemoradiotherapy, locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC;
  • EGFR sensitive mutations prior to the first-line EGFR-TKI therapy;
  • Radiologically documented disease progression after the first-line EGFR-TKI;
  • MET amplification after disease progression following the first-line therapy;
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  • Having measurable lesions (in accordance with RECIST 1. 1 criteria);
  • United States Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
  • Expected survival >12 weeks;
  • Adequate bone marrow reserve or organ function
  • Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug;
  • Male subjects should be willing to agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. ;
  • Being able to take or swallow the drug orally.

Who cannot join

  • Patients with positive T790M mutations;
  • Previous treatment for c-MET;
  • Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years.;
  • Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC;
  • Currently having received antiangiogenic therapy or traditional Chinese medicine with antitumor indication、extensive radiotherapy 、palliative local radiotherapy, a major surgery,or participated in other drug clinical trials and received corresponding tudy drug etc;
  • Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment;
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  • 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;
  • Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs;
  • Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm;
  • Presence of meningeal metastases, spinal cord compression or active brain metastases prior to the start of study treatment;
  • Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug;
  • 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;
  • Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
  • Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease;
  • Pregnant or breastfeeding women;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 210000

Other trials in China

About this study

Official title: Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Savolitinib + Osimertinib Versus Pemetrexed + Platinum in Treatment of Patients With NSCLC With MET Amplification

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.

Read the detailed description

This is a multicenter, randomized, controlled, open, phase III clinical study to evaluate the clinical efficacy and safety of Savolitinib combined with Osimertinib in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.

Being tested
Savolitinib + Osimertinib, Pemetrexed + Cisplatin /Carboplatin
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.

  • Savolitinib + OsimertinibDrug

    Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

  • Pemetrexed + Cisplatin /CarboplatinDrug

    Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)

Study groups in NCT05015608
Study groupRoleWhat they receive
Savolitinib + OsimertinibExperimentalSavolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks)
Receives: Drug: Savolitinib + Osimertinib
Pemetrexed combined with platinumActive comparatorPemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)
Receives: Drug: Pemetrexed + Cisplatin /Carboplatin

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: 5 months after the last patient enrolled

Secondary outcomes (7)

  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: 5 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: 5 months after the last patient enrolled

  3. The disease control rate (DCR)

    the incidence of complete response, partial response and stable disease

    Measured: 5 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: 5 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: 5 months after the last patient enrolled

  6. Time to Response (TTR)

    the period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).

    Measured: 5 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: 5 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 posted20 Aug 2021
  2. Study start22 Nov 2021
  3. Primary completion22 Aug 2025
  4. Study completion22 Aug 2025

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
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015608
Sponsor's protocol ID
2020-504-00CH3
Acronym
SACHI
Status last verified
May 2026
First submitted
30 Jul 2021
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu S, Wang J, Yang N, Lv D, Chen L, Wu L, Li X, Sun L, Yu Y, Jin B, Yang L, Guo Y, Xu H, Yi T, Zeng A, Dong X, Chen J, Wang Z, Niu H, Cheng Y, Pan P, Deng P, Pan H, Min X, Bai J, Liu L, Zhang T, Li J, Fan S, Shi MM, Mok T, Su W; SACHI Study Group. Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2026 Jan 24;407(10526):375-387. doi: 10.1016/S0140-6736(25)01811-2. Epub 2026 Jan 13.

    PubMed 41544643

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Savolitinib + Osimertinib and Pemetrexed + Cisplatin /Carboplatin in people with Non-small Cell Lung Cancer, run by Hutchison Medipharma Limited 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 13 inclusion and 18 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: finished, as of the sponsor's last update on 27 May 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 5 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 NCT05015608, which also lists 1 linked publication.

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 27 May 2026.

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