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Non-Small Cell Lung CancerPhase 1/2NCT07231068

A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation

A Phase 1/2 study testing Dositinib mesylate tablets in people with Non-Small Cell Lung Cancer, run by Henan Genuine Biotech Co., Ltd. at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an open label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Dositinib mesylate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
5 sitesChina
Study dates
31 Oct 2022to 31 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old (including 18 and 75 years old), male or female.
  • Histologically or cytologically confirmed patients with locally advanced NSCLC (stage IIIB / IIIc) or metastatic NSCLC (stage IV) who are unable to undergo radical surgery or radiotherapy (International Alliance against cancer, 8th Edition, 2017).
  • Locally advanced or metastatic NSCLC patients who have documentation of disease progression (with imaging evidence) while on previous continuous treatments with EGFR-TKI (such as gefitinib, erlotinib, icotinib, afatinib, etc., excluding the third-generation EGFR TKI drugs), or cannot tolerate the treatments for various reasons (only applicable to dose escalation part).
  • Patients with confirmed EGFR activating mutations that are sensitive to EGFR TKI at any time after initial diagnosis, in dose escalation part including G719X, exon 19 deletion, L858R, L861Q, in dose expansion part including exon 19 deletion and L858R.
  • No prior systemic antitumor therapy for locally advanced or metastatic NSCLC (patients who have received first-line chemotherapy but not TKI treatment can be enrolled). Patients who have undergone radical surgery, radical chemoradiotherapy or adjuvant treatment (chemotherapy, radiotherapy) for early-stage NSCLC and have experienced disease recurrence or metastasis later can be enrolled (only applicable to dose expansion part).
  • According to RECIST 1.1 response evaluation criteria in solid tumours, the patient has at least one imaging (CT, MRI) measurable or evaluable lesion, and accurate and repeatable measurement can be made at baseline, such as CT or MRI. In the dose expansion part, for the 160 mg and 200 mg dose groups, at least one measurable intracranial lesion is required in 20 to 30 patients with brain metastases. The long diameter of the lesion is more than or equal to 10 mm (if the lesion is a metastatic lymph node, the short diameter is more than or equal to 15 mm), and the lesion has not received radiotherapy or biopsy in the past (if the patient has only one target lesion and needs biopsy, the target lesion can be biopsied, and the time interval between the biopsy and the baseline assessment of the tumor in the screening period must be more than 2 weeks, and the target lesion still meets the definition in RECIST1.1 after biopsy). The same test method should be used in the follow-up evaluations.
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  • Subjects with ECOG performance score of 0-1.
  • Patients whose life expectancy is at least 12 weeks.
  • Patients have adequate important organ functions during screening, including: a. The absolute neutrophil count (NEUT#) ≥ 1.5 x 10^9/L without using hematopoietic stimulating factor within 14 days before the first administration; b. Platelet count ≥ 100 x 10^9 / L without using hematopoietic stimulating factor or blood transfusion within 14 days before the first administration; c. Hemoglobin>90g/L without using hematopoietic stimulating factor or blood transfusion within 14 days before the first administration; d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN (ULN = upper limit of normal value) or ≤ 5 x ULN (patients with hepatic metastases); e. Total bilirubin ≤1.5 x ULN (ULN = upper limit of normal value) or ≤ 3 x ULN (patients with hepatic metastase); f. Coagulation function INR ≤ 1.5; g. Serum creatinine ≤ 1.5 x ULN (ULN = upper limit of normal value) and creatinine clearance rate (calculated by Cockcroft and Gault formula) ≥ 50ml / min.
  • Female subjects of childbearing age must confirm that the blood pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 90 days after the last administration.
  • In this program, female subjects of childbearing age are defined as sexually mature women. (1) No hysterectomy or bilateral oophorectomy is performed; (2) Natural amenorrhea doesn't last for 12 consecutive months (amenorrhea after cancer treatment does not exclude fertility) (i.e., menstruation occurred at any time in the previous 12 consecutive months); if the female partner of a male subject is fertile, the subject must agree to take adequate contraceptive measures from the first administration of the study treatment to 90 days after the last administration of the study treatment.
  • The subjects should give informed consent to the study and sign the informed consent form before the trial.

Who cannot join

  • Within 28 days before the first administration of the study treatment, the patients have used any chemotherapy drugs and / or immunotherapy drugs in the previous treatment regimen or clinical study; or have undergone major surgery (excluding vascular access establishment surgery) or received > 30Gy within 28 days before the first administration of the study treatment. In addition to the local palliative radiotherapy for bone metastases, the patient have used an experimental drug or other anticancer drugs in the previous treatment regimen or clinical study within 14 days before the first administration of the study treatment, or stopped using other experimental drugs or anticancer drugs for less than 5 ×half-life (e.g., erlotinib less than 8 days, gefitinib less than 10 days, icotinib less than 2 days, afatinib less than 8 days).
  • Patients who have used the third generation EGFR TKI drugs (such as Osimertinib, rociletinib (co-1686), olmutinib (hm61713), asp8273, egf816, Mefatinib, Avitinib, etc.).
  • Patients who participated in other therapeutic clinical trials within one month before the first administration (patients who discontinue the experimental drug after more than five half-lives of the drug can be included in the study).
  • The patients are using (or cannot stop using) CYP3A4 strong inhibitor or inducer or Chinese herbal medicine with anti-tumor indications.
  • Patients who did not recover from the adverse events caused by previous anti-tumor therapy (recovered to ≤ 1 grade) (except for alopecia).
  • Patients with other malignant tumors within 5 years before the start of treatment (except for basal cell carcinoma or squamous cell carcinoma of the skin that is not melanoma, breast / cervical carcinoma in situ, superficial bladder carcinoma and other carcinoma in situ who have received radical treatment and no evidence of recurrence).
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  • Any condition that affects the patients' swallowing of the drug and seriously affects the absorption or pharmacokinetic parameters of the investigational drug, including any kind of uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability of the patient to swallow the drug, history of gastrointestinal resection or surgery.
  • Patients with known organ transplantation.
  • Meet any of the following cardiac criteria: QTc interval > 450ms in male and > 470ms in female (QTc interval calculated by fridericia formula). All kinds of ECG morphological abnormalities with clinical significance, such as complete left bundle branch block, grade III block, grade II block, PR interval > 250ms. Various factors that may increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of immediate family members with long QT syndrome or unexplained sudden death before 40 years of age, and the use of any drug with known QT interval prolongation.
  • Past medical history: interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, active interstitial lung disease with clinical evidence; patients with active pulmonary tuberculosis (TB) who are receiving anti tuberculosis treatment or received anti tuberculosis treatment within one year before screening.
  • Pulmonary function test: forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) < 70%, FEV1% < 30%, or DLCO% < 40%.
  • Patients with spinal cord compression, or meningeal metastasis, or symptomatic and untreated brain metastasis (except those who are asymptomatic, stable, and do not need steroid therapy for more than 4 weeks before the start of study treatment).
  • The patients have a history of hypersensitivity to the active ingredients or inactive excipients of the study drug, drugs with chemical structure similar to the study drug or similar drugs, etc.).
  • At any time after the initial diagnosis, there are confirmed EGFR 20 exon insertion mutations.
  • Subjects are in the stage of acute infection and need medical treatment.
  • In the active stage of hepatitis B or hepatitis C: HBsAg positive and HBV DNA ≥ 10^3 copies/mL or ≥ 200 IU/mL (HBV DNA is required when HBsAg is positive), HCVAb positive and HCV-RNA ≥ 10^3 copies/mL (HCV-RNA is required when HCVAb is positive).
  • Subjects are HIV positive.
  • Subjects with a clear history of mental disorders and who have taken medication for treatment
  • Subjects have a history of drug abuse.
  • Pregnant or lactating women.
  • Women of childbearing age and fertile men can not take effective contraceptive measures during the period from signing the informed consent to 90 days after the last use of the study drug.
  • The researcher believes that there are other factors that may affect the results of the study and interfere with the whole process of the study, including past or existing physical conditions, treatment or laboratory abnormalities, etc.; or the researcher believes that participating in the study can not maximize the benefits of the patients.
  • Subjects are not suitable to participate in this study for any reason in the judgment of the researcher.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Junling Li contact

+86 138 0117 8891

drlijunling@vip.163.com

5 sites in 1 country

China5 sites, 4 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Withdrawn

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Recruiting

  • Henan Provincial Cancer Hospital

    Zhengzhou

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou

    Recruiting

Other trials in China

About this study

Official title: A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study on the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutations

This is an open label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.

Read the detailed description

Dositinib is an EGFR-TKI. There are two parts in the study. Phase I is dose escalation study, and Phase II is dose expansion study. Phase I will be conducted using 3+3 dose escalation method. In Phase II, 3 dose levels will be chosen to further evaluate the safety and efficacy of Dositinib.

Being tested
Dositinib mesylate tablets
Keywords
Non-Small Cell Lung Cancer, EGFR mutation, Dositinib
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.

  • Dositinib mesylate tabletsDrug

    Also called 90-1408

    Dose-escalation part: Subjects received 90-1408 at doses of 20, 40, 80, 160, 200 and 240 mg. A single oral dose was administered on Cycle 1 Day 1, then once daily from Day 8 onward. Dosing occurred in the morning, with 21 days of continuous treatment per cycle.

    Dose-expansion part: Subjects received 90-1408 orally at a dose of 80, 160 and 200 mg, administered once daily for 21 consecutive days per cycle.

Study groups in NCT07231068
Study groupRoleWhat they receive
ExperimentalExperimentalDose-escalation part and dose-expansion part
Receives: Drug: Dositinib mesylate tablets

What is being measured

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

  1. Incidence and Severity of Adverse Events (AEs)

    AEs are assessed based on NCI CTCAE v5.0.

    Measured: From enrollment to the end of the study, up to 28 days after the end of study treatment.

Secondary outcomes (16)

  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of 90-1408 in Single Administration

    Measured: Up to 144 hours post-dose.

  2. Pharmacokinetics (PK): Time to Maximum Plasma Concentration (Tmax) of 90-1408 in Single Administration

    Measured: Up to 144 hours post-dose.

  3. Pharmacokinetics (PK): Area Under the Plasma Concentration Curve (AUC) of 90-1408 in Single Administration

    Measured: Up to 144 hours post-dose.

  4. Pharmacokinetics (PK): Elimination Half-Life (t1/2) of 90-1408 in Single Administration

    Measured: Up to 144 hours post-dose.

  5. Pharmacokinetics (PK): Steady-State Valley Concentration (Css-min) of 90-1408 in Multiple Administration

    Measured: Up to Day 29.

  6. Pharmacokinetics (PK): Steady-State Peak Concentration (Css-max) of 90-1408 in Multiple Administration

    Measured: Up to Day 29.

  7. Pharmacokinetics (PK): Mean Steady-State Concentration (Css-ave) of 90-1408 in Multiple Administration

    Measured: Up to Day 29.

  8. Pharmacokinetics (PK): Elimination Half-Life (t1/2) of 90-1408 in Multiple Administration

    Measured: Up to Day 29.

  9. Effectiveness Evaluation: Overall Response Rate (ORR)

    Measured: Up to approximately 60 months.

  10. Effectiveness Evaluation: Duration of Response (DOR)

    Measured: Up to approximately 60 months.

  11. Effectiveness Evaluation: Disease Control Rate (DCR)

    Measured: Up to approximately 60 months.

  12. Effectiveness Evaluation: Progression-Free Survival (PFS)

    Measured: Up to approximately 60 months.

  13. Effectiveness Evaluation: Overall Survival (OS)

    Measured: From enrollment until death from any cause, up to approximately 60 months.

  14. Effectiveness Evaluation: Intracranial Progression-Free Survival (iPFS)

    Measured: Up to approximately 60 months.

  15. Effectiveness Evaluation: Intracranial Overall Response Rate (iORR)

    Measured: Up to approximately 60 months.

  16. Evaluation of Drug Metabolic Profiles: Metabolic Profiles of 90-1408 and Its Metabolites in Plasma and Urine

    Measured: 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 posted17 Nov 2025
  2. Study start31 Oct 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

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
Sequential
Masking
None (open label)
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07231068
Sponsor's protocol ID
YD-Dox-200511
Status last verified
Nov 2025
First submitted
24 Sep 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
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 Dositinib mesylate tablets in people with Non-Small Cell Lung Cancer, run by Henan Genuine Biotech Co., Ltd. at 5 sites 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 12 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Junling Li (+86 138 0117 8891, drlijunling@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (AEs) (time frame: From enrollment to the end of the study, up to 28 days after the end of study treatment.). 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 NCT07231068.

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 17 Nov 2025.

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