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

NCT04992858 | Unknown Phase 2

• 1 other identifier: CT053-NSCLC-201
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Advanced NSCLC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Duration of response

  up to 4 years

• Progression-free survival

  up to 4 years

• Overall survival

  up to 4 years

• Disease Control Rate

  up to 4 years

• Adverse events related to CT053

  up to 4 years

Study Arms (1)

CT053PTSA

EXPERIMENTAL

60 mg/d, starting on the first day

Drug: CT053PTSA

Interventions

CT053PTSA DRUG

CT053PTSA will be administered orally once a day

Also known as: Ningetinib

CT053PTSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

(086)020-87343458; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 5, 2021
• Study Start: November 27, 2022
• Primary Completion: September 9, 2024
• Study Completion: December 9, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share