Non-small Cell Lung Cancer Metastatic Clinical Trial
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
Status | Recruiting |
Enrollment | 163 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; 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. 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; 3. 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; |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Hutchison Medipharma Limited |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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 | |
Secondary | 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 | through study completion, an average of 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01523340 -
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
|
||
Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
Active, not recruiting |
NCT02035683 -
PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy
|
N/A | |
Completed |
NCT01848613 -
Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
|
Phase 4 | |
Suspended |
NCT01320501 -
Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 4 | |
Terminated |
NCT01471964 -
Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT06127940 -
K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
|
Phase 1 | |
Terminated |
NCT04069936 -
Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC
|
Phase 2 | |
Terminated |
NCT03445000 -
ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03386929 -
Survival Prolongation by Rationale Innovative Genomics
|
Phase 1/Phase 2 | |
Recruiting |
NCT02922764 -
A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer
|
Phase 1 | |
Terminated |
NCT01574300 -
Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
|
||
Active, not recruiting |
NCT04646824 -
Almonertinib With Chemotherapy in mEGFR NSCLC
|
Phase 2 | |
Completed |
NCT01966003 -
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 3 | |
Recruiting |
NCT03656094 -
Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors
|
Phase 2 | |
Terminated |
NCT01348126 -
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03469960 -
Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr
|
Phase 3 | |
Recruiting |
NCT05919264 -
FOG-001 in Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT04793815 -
Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE)
|
N/A | |
Terminated |
NCT01380795 -
Feasibility of the Research for Mutation of K-ras and EGFR in CTCs From Metastatic Non Small Cells Bronchial Carcinomas
|
Early Phase 1 |