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New treatment option for Non-Small Cell Lung Cancer
Official title Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06706713
What this study is testing
What is BEBT-109 Capsule?
BEBT-109 Capsule is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as KCBT-1083.
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 study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.
- 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 and older
You may be able to join if
- people who have been fully informed and are willing to sign the informed consent form.
- Age of at least 18 years, with no gender restrictions.
- According to the 8th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor Node Metastasis (TNM) staging criteria...
- Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.
- Cohort 1 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one...
You likely can't join if
- Individuals who have had other malignant tumors within 5 years prior to enrollment, except for basal cell carcinoma of the skin that has been removed...
- Those who have previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081, or...
- Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy...
- Received medication from another clinical trial within 4 weeks prior to the first administration of the study treatment.
- Undergone major surgery (excluding vascular access procedures) within 4 weeks prior to the first administration of the study treatment.
- Currently using or having used within 1 week known strong inhibitors or inducers of CYP3A4 and CYP2C8, including medications or herbal supplements.
See the full eligibility criteria
Who can join
- people who have been fully informed and are willing to sign the informed consent form.
- Age of at least 18 years, with no gender restrictions.
- According to the 8th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor Node Metastasis (TNM) staging criteria: histologically or cytologically confirmed locally advanced (stages IIIB or IIIC...
- Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.
- Cohort 1 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen) and...
- Eastern Cooperative Oncology Group (ECOG) score of 0-2, with no decline in physical performance in the past two weeks, and an expected survival of at least 12 weeks.
- people must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- Laboratory tests indicate that people have adequate organ function: including: a. Absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count (PLT) ≥100×10\^9/L; hemoglobin (HGB) ≥80g/L; b. Serum total bilirubin (TBIL)...
- If the subject is a female with childbearing potential, she must use adequate contraceptive measures (such as condoms), must not breastfeed, and must have a negative blood pregnancy test before dosing.
- male people must be willing to use barrier contraceptive measures during the study period, i.e., condoms.
What rules you out
- Individuals who have had other malignant tumors within 5 years prior to enrollment, except for basal cell carcinoma of the skin that has been removed and cured, in situ bladder cancer, or in situ cervical cancer.
- Those who have previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081, or high-dose third-generation EGFR TKIs (Osimertinib \> 80 mg/day...
- Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy, or other biological therapies; for Mitomycin or Nitrosoureas...
- Received medication from another clinical trial within 4 weeks prior to the first administration of the study treatment.
- Undergone major surgery (excluding vascular access procedures) within 4 weeks prior to the first administration of the study treatment.
- Currently using or having used within 1 week known strong inhibitors or inducers of CYP3A4 and CYP2C8, including medications or herbal supplements.
- At the start of the study treatment, unresolved toxicities from previous treatments that are more than Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia, and...
- Spinal cord compression, meningeal metastasis, or brain metastasis, except for those who are asymptomatic, stable, and have not required steroid medication within 4 weeks prior to the start of the study treatment.
- Patients with symptomatic and unstable pleural effusion or ascites.
- Those with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for the trial by the investigator, including hypertension, diabetes, chronic heart failure (New York Heart Association (NYHA)...
- Individuals with uncontrolled active infections.
- Clinically significant active infections, including Hepatitis B (HBV) and Hepatitis C (HCV). Active Hepatitis B is defined as Hepatitis B surface antigen (HBsAg) positive with detectable HBV DNA copies above the upper...
- History of immunodeficiency, including positive Human Immunodeficiency Virus (HIV) antibody tests, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- At rest, the average corrected QT interval (QTc) from three Electrocardiogram (ECG) examinations is \>450 msec (only if the first ECG suggests QTc \>450 msec, two more measurements are required, and the average of the...
- Various severe and clinically significant cardiac rhythm, conduction, and resting ECG morphological abnormalities, such as complete left bundle branch block, third-degree block, second-degree block, PR interval \>250...
- Various factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia (low potassium levels indicated in the screening period blood chemistry, except for those who have...
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
- Uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow drug formulations, or previous extensive bowel resection, which may affect the adequate absorption of BEBT-109.
- History of hypersensitivity reaction to excipients in the BEBT-109 formulation.
- Female people who are breastfeeding.
- The investigator determines that the subject has any clinical or laboratory examination abnormalities or other reasons that make them unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Changsha, Hunan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Changsha, Hunan, 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.