Ningetinib in Advanced NSCLC Skipping Mutations With MET Exon 14 Skipping Mutations

A Phase II Study of the Ningetinib in Advanced NSCLC With MET Exon 14 Skipping Mutations

This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations

Study Overview

• Status: Withdrawn
• Conditions: Advanced NSCLC
• Intervention / Treatment: Drug: CT053PTSA

Detailed Description

This study is being carried out in two parts, part 1 and part 2. Part 1:Observation phase of dose tolerance: Objective To observe the tolerability and safety of 60 mg CT053PTSA in advanced NSCLC patients with Metex14 skipping mutation, and to determine the recommended dose (RED) in the dose expansion phase。 Part 2: This is the expansion part and will continue to evaluate the safety and efficacy of CT053PTSA at the dose of RED in advanced NSCLC patients with Metex14 skipping mutation.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age:18-75 years, male or female.
• Histologically or cytologically confirmed IIIB-IV- Advanced NSCLC
• There was a Metex 14 skipping mutation in plasma and / or tissue
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 ~2
• Life expectancy of greater than 12 weeks.
• Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Adequate organ function.
• Contraception, fertility and not lactating female subjects: screening blood pregnancy test must be negative
• Voluntarily join the study and sign informed consent ad has good compliance.

Exclusion Criteria:

• EGFR or ALK or ROS1 gene mutation was positive
• Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;other anti-tumor therapies within 4 weeks, Previously or currently participating in other clinical trials within 4 week, Prior therapies with c-MET targeted drugs; Had received vaccine within 4 weeks prior to study treatment or had a plan to receive vaccine during the trial.
• Not recovered from adverse events due to a previously administered agent.
• Symptomatic, untreated or unstable central nervous system metastases/ spinal cord compression, cancerous meningitis, or meningitis.
• Patients with other malignant tumors except NSCLC within 5 years before the first use of drugs do not include those with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and expected to be cured after treatment, or any other tumors that have been cured (no evidence of recurrence within 5 years)
• There are prescribed cardiovascular and cerebrovascular risk factors
• Patients with evidence of bleeding tendency, or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
• History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.
• There are uncontrollable and active infections
• Uncontrollable massive pleural / ascites or pericardial effusion
• Clinically significant gastrointestinal abnormalities may affect the drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy subjects;
• a history of psychotropic drug abuse and can not quit or have mental disorders
• Any other reason the investigator considers the patient is not suitable to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT053PTSA; 60 mg/d, starting on the first day	Drug: CT053PTSA; CT053PTSA will be administered orally once a day; Other Names: Ningetinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Extended Dose	Recommended dose for expansion phase	Cycle 1Day 1 to Cycle 1 Day 28±3
Objective response rate	Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by investigators	up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response	Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first. Includes participants with complete response or partial response	up to 4 years
Progression-free survival	defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.	up to 4 years
Overall survival	Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.	up to 4 years
Disease Control Rate	proportion of patients with best overall response of CR, PR or stable disease (SD)	up to 4 years
Adverse events related to CT053	description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]), severity, seriousness, and relatedness	up to 4 years

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Principal Investigator: Li Zhang, MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): November 27, 2022
• Primary Completion (Estimated): September 9, 2024
• Study Completion (Estimated): December 9, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CT053-NSCLC-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No