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Non-small Cell Lung CancerPhase 1/2NCT03758287

Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative

A Phase 1/2 study testing CT053PTSA and Gefitinib in people with Non-small Cell Lung Cancer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
CT053PTSA and Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
Nov 2016to 17 Sep 2021
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed Stage IIIB or IV NSCLC
  • Resistance to EGFR TKI (1st, 2nd or 3rd generation)
  • Histological or cytological evidence of EGFR mutation and T790M negative after progression on last EGFR TKI therapy
  • c-Met GCN ≥ 6 or cluster amplification is required if participant is resistant to1st or 2nd generation EGFR-TKI ;c-MET GCN statue is not required, If participant is resistant to3rd generation EGFR-TKI （osimertinib）；
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
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  • ECOG performance status (PS) 0 or 1
  • Life expectancy of ≥ 12 weeks
  • Adequate organ function

Who cannot join

  • Prior treatments
  • Chemotherapy, targeted therapy (except EGFR TKI), immunotherapy, radiotherapy, or major surgery within 4 weeks prior to study treatment
  • Nitrosourea and mitomycin chemotherapy within 6 weeks prior to study treatment
  • EGFR TKI treatment within 2 weeks prior to study treatment
  • Had received live vaccine within 4 weeks prior to study treatment
  • Had received any investigational agent from other clinical study within 4 weeks prior to study treatment or are currently participating in other clinical trials
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  • Previous treatment with any other c-MET inhibitor or Axl inhibitor (eg, crizotinib, cabozantinib, volitinib, INC280)
  • Symptomatic, untreated or unstable central nervous system metastases
  • Spinal cord compression, carcinomatous meningitis or leptomeningeal diseaseonly (patient are only permitted if treated, asymptomatic and stable for at least 4 weeks prior to start of study treatment)
  • Interstitial pneumonia or radiation pneumonitis
  • Uncontrolled hypertension that require more than two anti-hypertensive agents to control, or systolic blood pressure (BP) >140mmHg or diastolic BP >90 mmHg before the first administration (BP is the mean blood pressure of two measures that 1 hours interval or above)
  • Doppler ultrasound evaluation：Left ventricular ejection fraction < 50%
  • Grade ≥ 2 of arrhythmia (assessed by NCI CTCAE 4.03), or symptomatic bradycardia, or male with QTCF > 450 ms or female with QTCF > 470 ms, or patients with a history of torsion or congenital QT prolonged syndrome long QT syndrome
  • Certain factors that would preclude adequate absorption of CT053PTSA and gefitinib (eg. unable to swallow, chronic diarrhea, intestinal obstruction)
  • Significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above
  • Patients with evidence of bleeding tendency, including the following cases: gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above; or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
  • History of immunodeficiency, or other acquired or congenital immunodeficiency, or history of organ transplantation
  • Any disease of the following bellowed within 12 months prior to administration: Myocardial infarction, severe angina, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure, or cerebrovascular events (including transient ischemic attack)
  • Pulmonary embolism within 6 months prior to administration
  • Active infection of hepatitis B, or infection of HIV
  • Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
  • History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.
  • Serious electrolyte imbalance in the investigator's judgment
  • Pregnant or lactating woman
  • Any other reason the investigator considers the patient is not suitable to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Phase Ib, Multi-center, Open Label Study of Ningetinib (CT053PTSA) in Combination With Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative Who Have Progressed After EGFR TKI Therapy

This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment.

Read the detailed description

This study is being carried out in two parts, part 1 and part 2.

Part 1: This is the dose-escalation part. The primary purpose of the part 1 portion is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the appropriate doses of CT053PTSA in combination with gefitinib for further studies.

Part 2: This is the expansion part. The part 2 portion of this study will continue to evaluate the safety and efficacy of the combination of CT053PTSA and gefitinib , at the appropriate doses recommended in Part 1, in patients with EGFR mutation, T790M negative NSCLC.

Being tested
CT053PTSA, Gefitinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CT053PTSADrug

    Also called Ningetinib

  • GefitinibDrug

    Also called Iressa

Study groups in NCT03758287
Study groupRoleWhat they receive
CT053PTSA +GefitinibExperimentalPatients will receive CT053PTSA and gefitinib over a 28-day cycle until progressive disease, intolerable toxicity or subject's withdrawal from treatment. CT053PTSA will be administered daily, at a dose of 30 mg/40mg/60mg orally . Gefitinib will be administered daily, at a dose of 250 mg orally .
Receives: Drug: CT053PTSA; Drug: Gefitinib

What is being measured

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

  1. Part 1（dose-escalation part）: Maximum Tolerated Dose (MTD)

    The maximum tolerated dose (MTD) of the CT053PTSA and gefitinib combination will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.03

    Measured: Cycle 1 Day 1 to Cycle 1 Day 28

  2. Part 2（expansion part）: Overall Response Rate

    Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1

    Measured: up to approximately 36 months

Secondary outcomes (8)

  1. Number of patients with adverse events (AEs) as a measure of safety and tolerability

    Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs

    Measured: up to approximately 36 months

  2. Disease Control Rate (DCR)

    DCR, proportion of patients with best overall response of CR, PR or SD

    Measured: up to approximately 36 months

  3. Progression-free Survival (PFS)

    PFS, defined as time from date of treatment to disease progression or death due to any cause

    Measured: up to approximately 36 months

  4. Duration of Response (DOR)

    DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

    Measured: up to approximately 36 months

  5. Overall Survival (OS)

    OS, defined as time from date of treatment to death due to any cause

    Measured: up to approximately 60 months

  6. Maximum observed plasma concentration (Cmax)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

  7. Time of maximum observed plasma concentration (Tmax)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

  8. Area under the plasma concentration time curve (AUC)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

Timeline

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

  1. First posted29 Nov 2018
  2. Study startNov 2016
  3. Primary completion17 Sep 2021
  4. Study completion17 Sep 2021

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03758287
Sponsor's protocol ID
PCD-DCT053-16-001
Status last verified
May 2026
First submitted
27 Nov 2018
Last updated
12 May 2026
Results posted
No
Data monitoring committee
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 1/2 study testing CT053PTSA and Gefitinib in people with Non-small Cell Lung Cancer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

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 25 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part 1（dose-escalation part）: Maximum Tolerated Dose (MTD) (time frame: Cycle 1 Day 1 to Cycle 1 Day 28). 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 NCT03758287.

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 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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