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

Advanced NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04992858
• Other study ID #: CT053-NSCLC-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 27, 2022
• Est. completion date: December 9, 2024

Study information

• Verified date: July 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: Li Zhang, MD
• Phone: (086)020-87343458
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 9, 2024
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• CT053PTSA
CT053PTSA will be administered orally once a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended Extended Dose	Recommended dose for expansion phase	Cycle 1Day 1 to Cycle 1 Day 28±3
Primary	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	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
Secondary	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
Secondary	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
Secondary	Disease Control Rate	proportion of patients with best overall response of CR, PR or stable disease (SD)	up to 4 years
Secondary	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