Non-Small Cell Lung CancerPhase 2NCT06706713
Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
A Phase 2 study testing BEBT-109 Capsule in people with Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation, run by BeBetter Med Inc at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, EGFR Exon 20 Insertion Mutation
- What is being tested?
- BEBT-109 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2022to 30 Jun 2026
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 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, and deemed unsuitable for surgery or radiotherapy by the investigator) or metastatic (stage IV) NSCLC.
- 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 have not received third-generation EGFR TKI treatment; Cohort 2 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 have experienced Progressive Disease after receiving standard doses of third-generation EGFR TKI (such as osimertinib 80 mg once daily, or savolitinib 80 mg once daily, or alectinib 110 mg once daily, etc.).
- 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.
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- Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- Laboratory tests indicate that subjects 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) ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (for those with liver metastasis, total bilirubin ≤3 times ULN, AST and ALT ≤5 times ULN are allowed); c. Creatinine ≤1.5 times ULN, when creatinine >1.5 times ULN, creatinine clearance must be confirmed, and creatinine clearance must be ≥45 ml/min (actual value, or calculated by the Cockcroft-Gault formula); d. Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.
- 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 subjects must be willing to use barrier contraceptive measures during the study period, i.e., condoms.
Who cannot join
- 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, Furmonertinib > 80 mg/day, or Almonertinib > 110 mg/day, etc.).
- 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, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer).
- 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.
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- 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 neurotoxicity related to previous platinum treatment can be relaxed to Grade 2.
- 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) class III-IV), unstable angina, myocardial infarction within 1 year, active bleeding, etc..
- 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 limit of normal of the testing laboratory. Patients with HBV DNA copies above the normal limit are allowed to receive antiviral treatment before screening to reduce the viral load to below the normal limit, but must continue antiviral treatment for Hepatitis B during the trial; Active Hepatitis C is defined as HCV RNA above the detection limit.
- 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 three values is taken).
- 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 msec, etc..
- 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 been treated with potassium supplements and rechecked as normal before the first dose), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death before the age of 40.
- 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 subjects 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
You Luo, Bachelor, +86-18198862173, yluo@bebettermed.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wei Wu, Bachelor, +86-15626442934, wwu@bebettermed.com
About this study
Official title: An Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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）.
Read the detailed description
This study is designed with two cohorts, each comprising approximately 100 subjects. Cohort 1 includes subjects with EGFR exon 20 insertion mutations in NSCLC who have failed or are intolerant to at least one systemic chemotherapy and have not received third-generation EGFR (Tyrosine Kinase Inhibitor) TKI therapy. Cohort 2 includes subjects with EGFR exon 20 insertion mutations in NSCLC who have failed or are intolerant to at least one systemic chemotherapy and have experienced Progressive Disease after receiving standard-dose third-generation EGFR TKI therapy.Subjects receive BEBT-109 capsules treatment with a dosage of 120mg bid (twice a day), and each 28-day period constitutes a cycle. In case of intolerance during the treatment, dose adjustments can be made according to the adjustment plan.
Each subject's study process includes three phases: the screening period, the treatment period, and the post-treatment follow-up period. The screening period can last up to 28 days.During the treatment period, tumor assessments are conducted every 8 weeks (±7 days). If the initial response is Partial Response (PR) or Complete Response (CR ), a confirmation assessment for efficacy is required between 4-6 weeks. Subjects can continue to receive study medication until Progressive Disease (PD), death, intolerable toxicity occurs, or the subject withdraws informed consent (whichever comes first). After discontinuing treatment, subjects will enter the post-treatment follow-up period, receiving efficacy follow-ups every 8 weeks (±7 days) (until tumor progression or other anti-tumor treatments are administered) and survival follow-ups every 3 months (±7 days).
When a subject experiences the first instance of Progressive Disease, if the investigator believes that continued use of the study medication may still be beneficial, the subject is allowed to continue receiving study medication until imaging indicates no clinical benefit.
- Being tested
- BEBT-109 Capsule
- Keywords
- BEBT-109, EGFR Exon 20 Insertion Mutations, Efficacy, Safety
- 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.
BEBT-109 CapsuleDrug
Also called KCBT-1083
Take orally before breakfast and dinner each day, with a minimum interval of 9 hours between doses, 120mg each time, twice a day,and 28 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| BEBT-109 Capsule Treatment | Experimental | BEBT-109 Capsule: Administration and dosage: Oral administration, 120mg; Frequency and duration of administration: Twice a day,and 28 days as a treatment cycle. Receives: Drug: BEBT-109 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: Every 8 weeks,assessed up to 24 months.
PFS
Progression-Free Survival
Measured: Every 8 weeks,assessed up to 24 months.
Secondary outcomes (5)
DOR
Duration of Response
Measured: Every 8 weeks,assessed up to 24 months.
DCR
Disease Control Rate
Measured: Every 8 weeks,assessed up to 24 months.
TTR
Time to Response
Measured: Every 8 weeks,assessed up to 24 months.
OS
Overall Survival
Measured: From date of administration until date of death from any cause, assessed up to 24 months.
Adverse Events
Safety and tolerability are assessed through imaging examinations, systemic adverse events, and laboratory abnormalities.
Measured: From the first dose of medication to 30 days after the last dose in subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This study is designed with two cohorts, each comprising approximately 100 subjects. Subjects receive BEBT-109 capsules treatment with a dosage of 120mg bid (twice a day), and each 28-day period constitutes a cycle. In case of intolerance during the treatment, dose adjustments can be made according to the adjustment plan.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeBetter Med Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nong Yang, Phd, Principal investigator, Hunan Cancer HospitalYilong Wu, Phd, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706713
- Sponsor's protocol ID
- GBMT-109-P02
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06706713
- Acronym / sponsor ID
- GBMT-109-P02
- Keywords
- BEBT-109, EGFR Exon 20 Insertion Mutations, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BeBetter Med IncIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）.
Detailed description
This study is designed with two cohorts, each comprising approximately 100 subjects. Cohort 1 includes subjects with EGFR exon 20 insertion mutations in NSCLC who have failed or are intolerant to at least one systemic chemotherapy and have not received third-generation EGFR (Tyrosine Kinase Inhibitor) TKI therapy. Cohort 2 includes subjects with EGFR exon 20 insertion mutations in NSCLC who have failed or are intolerant to at least one systemic chemotherapy and have experienced Progressive Disease after receiving standard-dose third-generation EGFR TKI therapy.Subjects receive BEBT-109 capsules treatment with a dosage of 120mg bid (twice a day), and each 28-day period constitutes a cycle. In case of intolerance during the treatment, dose adjustments can be made according to the adjustment plan.
Each subject's study process includes three phases: the screening period, the treatment period, and the post-treatment follow-up period. The screening period can last up to 28 days.During the treatment period, tumor assessments are conducted every 8 weeks (±7 days). If the initial response is Partial Response (PR) or Complete Response (CR ), a confirmation assessment for efficacy is required between 4-6 weeks. Subjects can continue to receive study medication until Progressive Disease (PD), death, intolerable toxicity occurs, or the subject withdraws informed consent (whichever comes first). After discontinuing treatment, subjects will enter the post-treatment follow-up period, receiving efficacy follow-ups every 8 weeks (±7 days) (until tumor progression or other anti-tumor treatments are administered) and survival follow-ups every 3 months (±7 days).
When a subject experiences the first instance of Progressive Disease, if the investigator believes that continued use of the study medication may still be beneficial, the subject is allowed to continue receiving study medication until imaging indicates no clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed with two cohorts, each comprising approximately 100 subjects. Subjects receive BEBT-109 capsules treatment with a dosage of 120mg bid (twice a day), and each 28-day period constitutes a cycle. In case of intolerance during the treatment, dose adjustments can be made according to the adjustment plan.
| Arm | Type | Receives |
|---|---|---|
| BEBT-109 Capsule Treatment | Experimental | Drug: BEBT-109 CapsuleBEBT-109 Capsule: Administration and dosage: Oral administration, 120mg; Frequency and duration of administration: Twice a day,and 28 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects 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, and deemed unsuitable for surgery or radiotherapy by the investigator) or metastatic (stage IV) NSCLC.
- 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 have not received third-generation EGFR TKI treatment; Cohort 2 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 have experienced Progressive Disease after receiving standard doses of third-generation EGFR TKI (such as osimertinib 80 mg once daily, or savolitinib 80 mg once daily, or alectinib 110 mg once daily, etc.).
Key exclusion criteria (21 listed)
- 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, Furmonertinib > 80 mg/day, or Almonertinib > 110 mg/day, etc.).
- 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, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEBT-109 CapsuleAlso: KCBT-1083Take orally before breakfast and dinner each day, with a minimum interval of 9 hours between doses, 120mg each time, twice a day,and 28 days as a treatment cycle. | Drug | BEBT-109 Capsule Treatment |
Primary outcome
ORR
Time frame: Every 8 weeks,assessed up to 24 months.
Objective Response Rate
PFS
Time frame: Every 8 weeks,assessed up to 24 months.
Progression-Free Survival
5 secondary outcomes
DOR
Time frame: Every 8 weeks,assessed up to 24 months.
DCR
Time frame: Every 8 weeks,assessed up to 24 months.
TTR
Time frame: Every 8 weeks,assessed up to 24 months.
OS
Time frame: From date of administration until date of death from any cause, assessed up to 24 months.
Adverse Events
Time frame: From the first dose of medication to 30 days after the last dose in subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nong Yang, Phd principal investigator
Hunan Cancer Hospital
Yilong Wu, Phd principal investigator
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEBT-109 Capsule in people with Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation, run by BeBetter Med Inc at 2 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 10 inclusion and 21 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
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 Kegang Jiang, Master (+86-18664786382, kjiang@bebettermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Every 8 weeks,assessed up to 24 months.). 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?
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 26 Nov 2024.