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

NCT04923945 | Completed Phase 3

• 1 other identifier: 2020-504-00CH2
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (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

  through study completion, an average of 3 years

Secondary Outcomes (2)

• Progression-free survival (PFS) (RECIST 1.1 criteria)

  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

• incidence of various adverse events (AE)

  through study completion, an average of 3 years

Study Arms (1)

Savolitinib

EXPERIMENTAL

NSCLC

Drug: Savolitinib

Interventions

Savolitinib DRUG

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.

Savolitinib

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 210000, China

Location

Related Publications (1)

• 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.

  PMID: 39270695 DERIVED

MeSH Terms

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

Study Officials

• Shun Lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 11, 2021
• Study Start: August 19, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)