Clinical trial · Interventional
Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients
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
NCT04923945CI-TRIAL-00086925completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Savolitinib | Drug | Savolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Savolitinib
- description
- NSCLC
- interventionNames
- Drug: Savolitinib
Primary outcomes (1)
- measure
- Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
- timeFrame
- through study completion, an average of 3 years
- description
- To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations
Secondary outcomes (2)
- measure
- Progression-free survival (PFS) (RECIST 1.1 criteria)
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure; 2. Age ≥18 years; 3. Histologically diagnosed locally advanced or metastatic NSCLC with MET exon 14 mutation; 4. 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; 5. Having measurable lesions (in accordance with RECIST 1.1 criteria); 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, or Karnofsky performance status ≥80; 7. Survival is expected to exceed 12 weeks; 8. Adequate functionality in bone marrow, liver, kidney 9. Able to take or swallow the drug orally. 10. 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; Exclusion Criteria: 1. Having gene mutations sensitive to targeted drugs for EGFR, ALK and ROS1; 2. Previous anti-MET therapy (including but not limited to crizotinib, Onartuzumab, etc.) 3. 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; 4. 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;
References
Publications (2)
- DERIVEDYu 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. PMID 41938023
- DERIVEDYu 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