AzTrials
AzTrials

Advanced NSCLCPhase 2NCT04992858

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

A Phase 2 study testing CT053PTSA in people with Advanced NSCLC, run by Sunshine Lake Pharma Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced NSCLC
What is being tested?
CT053PTSA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
27 Nov 2022to 9 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

About this study

Official title: 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

Read the 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.

Conditions
Advanced NSCLC
Being tested
CT053PTSA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT053PTSADrug

    Also called Ningetinib

    CT053PTSA will be administered orally once a day

Study groups in NCT04992858
Study groupRoleWhat they receive
CT053PTSAExperimental60 mg/d, starting on the first day
Receives: Drug: CT053PTSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Extended Dose

    Recommended dose for expansion phase

    Measured: Cycle 1Day 1 to Cycle 1 Day 28±3

  2. 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

    Measured: up to 4 years

Secondary outcomes (5)

  1. 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

    Measured: up to 4 years

  2. 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.

    Measured: up to 4 years

  3. 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.

    Measured: up to 4 years

  4. Disease Control Rate

    proportion of patients with best overall response of CR, PR or stable disease (SD)

    Measured: up to 4 years

  5. Adverse events related to CT053

    description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]), severity, seriousness, and relatedness

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start27 Nov 2022 (estimated)
  3. Primary completion9 Sep 2024 (estimated)
  4. Study completion9 Dec 2024 (estimated)

Why it stopped: Withdrawn proactively due to the company's development strategy adjustment and changes in the drug R\&D direction.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04992858
Sponsor's protocol ID
CT053-NSCLC-201
Status last verified
May 2026
First submitted
14 Jul 2021
Last updated
14 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT053PTSA in people with Advanced NSCLC, run by Sunshine Lake Pharma Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Extended Dose (time frame: Cycle 1Day 1 to Cycle 1 Day 28±3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in