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Non-small Cell Lung Cancer MetastaticPhase 3NCT04923945

Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

A Phase 3 study testing Savolitinib in people with Non-small Cell Lung Cancer Metastatic, 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

Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
Savolitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteChina
Study dates
19 Aug 2021to 30 Nov 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
  • Age ≥18 years;
  • Histologically diagnosed locally advanced or metastatic NSCLC with MET exon 14 mutation;
  • Cohort 1: disease progression or intolerable toxicity after previous therapy with platinum-based chemotherapeutic regimen (for the patients who have received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy previously or radical radiochemotherapy for progressive disease, if the disease progression occurred < 6 months after the end of the last therapy, the patient belongs to failure after the first-line therapy); Cohort 2: no any previous systematic antitumor therapy for advanced diseases; Cohort 3: no any previous systematic antitumor therapy for advanced diseases;
  • Having measurable lesions (in accordance with RECIST 1.1 criteria);
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, or Karnofsky performance status ≥80;
Show all 10Show fewer
  • Survival is expected to exceed 12 weeks;
  • Adequate functionality in bone marrow, liver, kidney
  • Able to take or swallow the drug orally.
  • Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;

Who cannot join

  • Having gene mutations sensitive to targeted drugs for EGFR, ALK and ROS1;
  • Previous anti-MET therapy (including but not limited to crizotinib, Onartuzumab, etc.)
  • Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
  • Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;

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: A Multi-center, Open-label, Phase IIIb Confirmatory Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Locally Advanced or Metastatic NSCLC Patients With MET Exon 14mutations

Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib

Read the detailed description

This is a single-arm, multi-cohort, multi-center, open-label, phase IIIb clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations. The study involves a Screening Period, a Treatment Period and a Follow-up Period. There are 53 study sites initiated and enrolled 203 advanced or metastatic NSCLC patients with MET exon 14 mutations

Being tested
Savolitinib

What participants receive

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

  • SavolitinibDrug

    Patients meeting the study inclusion criteria will receive Savolitinib [Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest. Or patient will receive Savolitinib [Savolitinib 300 mg, po, twice per day (BID) continuously in patients with baseline weight ≥50 kg, and Savolitinib 200 mg, po, BID in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.

Study groups in NCT04923945
Study groupRoleWhat they receive
SavolitinibExperimentalNSCLC
Receives: Drug: Savolitinib

What is being measured

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

  1. Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)

    To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations

    Measured: through study completion, an average of 3 years

Secondary outcomes (2)

  1. Progression-free survival (PFS) (RECIST 1.1 criteria)

    To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  2. incidence of various adverse events (AE)

    To evaluate the safety and tolerability of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations

    Measured: through study completion, an average of 3 years

Timeline

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

  1. First posted11 Jun 2021
  2. Study start19 Aug 2021
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

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
Not applicable
Intervention model
Single group
Model description
locally advanced or metastatic NSCLC patients with MET exon 14 mutations without EGFR, ALK and ROS1 sensitive mutations who had disease progression or intolerable toxicity after previous therapy with platinum-based chemotherapeutic regimen and are treatment-naïve to c-MET therapy OR who did not receive any drug therapy for advanced tumors previously.
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923945
Sponsor's protocol ID
2020-504-00CH2
Status last verified
Mar 2025
First submitted
30 May 2021
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu Y, Guo Q, Zhang Y, Fang J, Zhong D, Liu B, Pan P, Lv D, Wu L, Zhao Y, Li J, Liu Z, Liu C, Su H, Fan Y, Zhang T, Liu A, Jin B, Wang Y, Zhou J, Zhang Z, Ran F, Song X, Shi MM, Su W, Lu S; study group. Efficacy and safety of savolitinib in Chinese patients with locally advanced or metastatic MET exon 14-mutated non-small cell lung cancer: final results of a confirmatory Phase 3b study. Lancet Reg Health West Pac. 2026 Mar 23;69:101834. doi: 10.1016/j.lanwpc.2026.101834. eCollection 2026 Apr.

    PubMed 41938023

  • Yu Y, Guo Q, Zhang Y, Fang J, Zhong D, Liu B, Pan P, Lv D, Wu L, Zhao Y, Li J, Liu Z, Liu C, Su H, Fan Y, Zhang T, Liu A, Jin B, Wang Y, Zhou J, Zhang Z, Ran F, Song X, Shi M, Su W, Lu S; study group. Savolitinib in patients in China with locally advanced or metastatic treatment-naive non-small-cell lung cancer harbouring MET exon 14 skipping mutations: results from a single-arm, multicohort, multicentre, open-label, phase 3b confirmatory study. Lancet Respir Med. 2024 Dec;12(12):958-966. doi: 10.1016/S2213-2600(24)00211-X. Epub 2024 Sep 10.

    PubMed 39270695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Savolitinib in people with Non-small Cell Lung Cancer Metastatic, 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 10 inclusion and 4 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 7 Mar 2025. 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?

Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria) (time frame: through study completion, an average of 3 years). 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 NCT04923945, which also lists 2 linked publications.

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 7 Mar 2025.

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