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

• ClinicalTrials.gov Identifier: NCT04923945
• Recruitment Status: Recruiting
• First Posted: June 11, 2021
• Last Update Posted: September 2, 2021
• Sponsor: Hutchison Medipharma Limited
• Information provided by (Responsible Party): Hutchmed ( Hutchison Medipharma Limited )

Tracking Information

• First Submitted Date: May 30, 2021
• First Posted Date: June 11, 2021
• Last Update Posted Date: September 2, 2021
• Actual Study Start Date: August 19, 2021
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2021)

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 ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 7, 2021)

• Progression-free survival (PFS) (RECIST 1.1 criteria) [ Time Frame: 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 ]
  To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations
• incidence of various adverse events (AE) [ Time Frame: through study completion, an average of 3 years ]
  To evaluate the safety and tolerability of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients
• 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
• Brief Summary: Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib
• 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. It is planned that about 40 study sites will enroll 163 advanced or metastatic NSCLC patients with MET exon 14 mutations
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment

• Condition: Non-small Cell Lung Cancer Metastatic

Intervention

Drug: Savolitinib

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.

Study Arms

Experimental: Savolitinib

NSCLC

Intervention: Drug: Savolitinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 7, 2021): 163
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tinghua Song; 19512230542; tinghuas@hutch-med.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04923945
• Other Study ID Numbers: 2020-504-00CH2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hutchmed ( Hutchison Medipharma Limited )
• Original Responsible Party: Same as current
• Current Study Sponsor: Hutchison Medipharma Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shun Lu, MD; Shanghai Chest Hospital

• PRS Account: Hutchmed
• Verification Date: August 2021