ClinicalTrials.gg
CompletedNCT05015608SACHIUpdated May 27, 2026

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

A Phase 3 interventional study of Savolitinib + Osimertinib and Pemetrexed + Cisplatin /Carboplatin in Non-small Cell Lung Cancer, sponsored by Hutchison Medipharma Limited. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Hutchison Medipharma Limited (part of HUTCHMED) · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 91 studies testing osimertinib in Carcinoma, Non-Small-Cell Lung — 21 open to participants now, 44 under way, 8 of them phase 3. osimertinib · Carcinoma, Non-Small-Cell Lung.

Enrollment
14th of 91
216 · median 50
Started
2021
with 9 others
Phase 3
12 of 91
1 open now
Registered
64th of 91
by date

Among the 91 studies testing osimertinib in Carcinoma, Non-Small-Cell Lung, this one is the 14th largest by enrollment, is one of 10 that started in 2021, is one of 12 in phase 3, and was the 64th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

21 of the 91 studies testing osimertinib in Carcinoma, Non-Small-Cell Lung are open now, in 8 countries. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 21 open studies →

About osimertinib

osimertinib: first FDA approval 2015 (TAGRISSO), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 91 studies testing osimertinib in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Non-small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Fully aware this study and voluntary to sign the form, and willing and able to comply with the study procedure;
  2. Age ≥ 18 and ≤75 years;
  3. 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 or cytologically confirmed unresectable and non-suitable for radical concurrent chemoradiotherapy, locally advanced or (stage IIIB, IIIC or IV) NSCLC;
  4. EGFR sensitive mutations prior to the EGFR-TKI therapy;
  5. Radiologically documented disease progression after the first-line EGFR-TKI;
  6. MET amplification after disease progression following the first-line therapy;
  7. Having (in accordance with 1. 1 criteria);
  8. United States (ECOG) Performance Status 0 or 1;
  9. Expected survival >12 weeks;
  10. Adequate bone marrow reserve or organ function
  11. Female patients of must agree to use effective methods from screening period to 4 weeks after discontinuation of the study drug;
  12. 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. ;
  13. Being able to take or swallow the drug orally.

Exclusion criteria

Exclusion Criteria:

  1. Patients with positive T790M mutations;
  2. Previous treatment for c-MET;
  3. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years.;
  4. Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC;
  5. 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;
  6. Currently receiving the potent inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment;
  7. Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment;
  8. active infection, including but not limited to tuberculosis, (HIV) infection (positive HIV1/2 antibody);
  9. Active , or active ;
  10. Acute myocardial infarction, unstable angina pectoris, stroke or ;
  11. Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs;
  12. Mean resting interval (QTcF) or Any important abnormality in rhythm;
  13. Presence of meningeal , spinal cord compression or active prior to the start of study treatment;
  14. Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug;
  15. 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;
  16. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
  17. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease;
  18. Pregnant or breastfeeding women;
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (actual)

Study arms

  • Experimental
    Savolitinib + Osimertinib

    Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks)

    Drug: Savolitinib + Osimertinib

  • Active comparator
    Pemetrexed combined with platinum

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

    Drug: Pemetrexed + Cisplatin /Carboplatin

Interventions

  • DrugSavolitinib + Osimertinib

    Drug pages: Savolitinib · Osimertinib

    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.

  • DrugPemetrexed + Cisplatin /Carboplatin

    Drug pages: Pemetrexed · Cisplatin · Carboplatin

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

06

What researchers measure

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).

    Time frame: 5 months after the last patient enrolled

Secondary outcomes

  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

    Time frame: 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

    Time frame: 5 months after the last patient enrolled

  3. The disease control rate (DCR)

    the incidence of complete response, partial response and stable disease

    Time frame: 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

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 5 months after the last patient enrolled

07

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality 210000, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Aug 2025, 45 months.

Of 315 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's 45 months is above that.

Counting every sponsor, half of 424 studies reached it within 45 months; a quarter within 30 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2021
First posted
Aug 20, 2021
StartActual
Nov 22, 2021
Primary completionActual
Aug 22, 2025
CompletionActual
Aug 22, 2025
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05015608
Responsible party
Sponsor
First posted
Aug 20, 2021
Start date
Nov 22, 2021
Primary completion
Aug 22, 2025
Completion
Aug 22, 2025
Last update
May 27, 2026

Study contacts

Shun Lu, MD
principal investigator · Shanghai Chest Hospital
Jie Wang, MD
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Savolitinib · Osimertinib

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