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New treatment option for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07231068
What this study is testing
What is Dositinib mesylate tablets?
Dositinib mesylate tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as 90-1408.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Locally advanced or metastatic NSCLC patients who have documentation of disease progression (with imaging evidence) while on previous continuous...
- Patients with confirmed EGFR activating mutations that are sensitive to EGFR TKI at any time after initial diagnosis, in dose escalation part...
- No prior systemic antitumor therapy for locally advanced or metastatic NSCLC (patients who have received first-line chemotherapy but not TKI...
You likely can't join if
- Within 28 days before the first administration of the study treatment, the patients have used any chemotherapy drugs and / or immunotherapy drugs in...
- Patients who have used the third generation EGFR TKI drugs (such as Osimertinib, rociletinib (co-1686), olmutinib (hm61713), asp8273, egf816...
- Patients who participated in other therapeutic clinical trials within one month before the first administration (patients who discontinue the...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- people 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...
- Female people 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...
- The people should give informed consent to the study and sign the informed consent form before the trial.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 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...
- 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.
- people 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...
- people are HIV positive.
- people with a clear history of mental disorders and who have taken medication for treatment
- people 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...
- people are not suitable to participate in this study for any reason in the judgment of the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangzhou, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangzhou, China; Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.