Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological ExaminationPhase 2NCT07410611
ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy
A Phase 2 study testing Befotertinib in people with Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination
- What is being tested?
- Befotertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 28 Feb 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at the time of signing the informed consent form, both males and females are eligible;
- Histologically confirmed newly diagnosed or treatment-naïve oligometastatic stage IV NSCLC (AJCC 9th edition) with ≤3 involved organs and ≤5 metastatic lesions. Regional lymph node involvement (regardless of number) is not counted as metastatic sites; non-regional lymph node involvement is classified as a metastatic lesion;
- Presence of an EGFR sensitizing mutation (19Del or 21L858R);
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status 0-1;
- Life expectancy ≥12 weeks;
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- No prior systemic anti-tumor therapy for advanced NSCLC, including standard chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational drug treatment before starting the study drug. Patients who have received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if there has been no progression within 6 months after completion of such therapy;
- Adequate organ function (no transfusion, growth factor support, or medical correction within 14 days before screening):
- Hematology:
- Hemoglobin (HB) ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet count (PLT) ≥100 × 10⁹/L;
- White blood cell count (WBC) ≥4.0 × 10⁹/L and ≤15 × 10⁹/L.
- Blood biochemistry (no transfusion or albumin infusion within 14 days before screening):
- AST and ALT ≤1.5 × ULN (≤5 × ULN if liver metastases are present);
- Alkaline phosphatase (ALP) ≤2.5 × ULN;
- Total bilirubin (TBiL) ≤1.5 × ULN;
- Albumin (ALB) ≥30 g/L;
- Serum creatinine (Cr) ≤1.5 × ULN and creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula);
- Activated partial thromboplastin time (APTT) ≤1.5 × ULN, and INR or PT ≤1.5 × ULN.
- Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion; a negative serum or urine pregnancy test within 7 days before enrollment is required, and the patient must not be breastfeeding. Male participants must agree to use contraception during the study and for 6 months afterward;
- Voluntary participation in the study, provision of written informed consent, good compliance, and willingness to provide blood samples.
Who cannot join
- Small cell lung cancer or non-small cell lung cancer mixed with histologic types such as small cell lung cancer or neuroendocrine carcinoma;
- Confirmed EGFR exon 20 insertion mutation or non-classical mutations such as L861Q, G719X, or S768I;
- Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc.);
- Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or imaging (CT or MRI) findings of brain or leptomeningeal disease at screening (except those with previously treated brain metastases who have been stable and without progression for ≥4 weeks before enrollment, and confirmed by brain MRI, CT, or venography to have no evidence of intracranial hemorrhage);
- Known history of hypersensitivity to the active or inactive excipients of Befotertinib or to drugs with similar chemical structures or classes;
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.;
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- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment;
- Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., that in the investigator's judgment would compromise patient participation or protocol compliance, or any active infection including uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
- QTc prolongation >470 ms or any clinically significant arrhythmia;
- Any condition that, in the investigator's judgment, would preclude participation in this study, including patients deemed unlikely to comply with study procedures, constraints, and requirements, or other situations at the investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
ZHOU, 0086-0311-86095588, chenk777@126.com
About this study
Official title: Dynamic ctDNA Monitoring Guides a Single-Arm, Multicenter, Exploratory Study of Befotertinib Combined With Radiotherapy for EGFR-Mutated Oligometastatic NSCLC
Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available third-generation EGFR-TKIs. Building on the clinical advantages of this agent and addressing the unmet therapeutic needs in oligometastatic NSCLC, this study aims to conduct a prospective exploration by dynamically monitoring circulating tumor DNA (ctDNA) to guide the application of befotertinib combined with radiotherapy in patients with EGFR mutation-positive oligometastatic NSCLC.
- Being tested
- Befotertinib
- 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.
BefotertinibDrug
Subjects will receive treatment with Befotertinib. Peripheral blood will be collected 8 weeks (±7 days) later for ctDNA testing. Those who test positive for ctDNA will undergo treatment intensification with Befotertinib combined with radiotherapy, while those who test negative will continue with Befotertinib monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Befotertinib | Other | Subjects will receive treatment with Befotertinib. Peripheral blood will be collected 8 weeks (±7 days) later for ctDNA testing. Those who test positive for ctDNA will undergo treatment intensification with Befotertinib combined with radiotherapy, while those who test negative will continue with Befotertinib monotherapy. Receives: Drug: Befotertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-Free Survival is defined as the time from the initiation of treatment until the first documented radiological progression of disease (PD) or death from any cause, whichever occurs first. If a subject has not experienced PD or death by the study cutoff date, or has received other antitumor therapy, the date of the last efficacy assessment before the cutoff date or the start date of other antitumor therapy (whichever is earlier) will be used as the censoring time.
Measured: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 mont
PFS
Progression-Free Survival (PFS) is defined as the time from the initiation of treatment until the first documented radiological progression of disease (PD) or death from any cause, whichever occurs first. If a subject has not experienced PD or death by the study cutoff date, or has received other antitumor therapy, the date of the last efficacy assessment before the cutoff date or the start date of other antitumor therapy (whichever is earlier) will be used as the censoring time.
Measured: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological ExaminationStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Zhou, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410611
- Sponsor's protocol ID
- BD-BF-IV034-2025
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic ctDNA Monitoring Guides a Single-Arm, Multicenter, Exploratory Study of Befotertinib Combined With Radiotherapy for EGFR-Mutated Oligometastatic NSCLC
- ClinicalTrials.gov ID
- NCT07410611
- Acronym / sponsor ID
- BD-BF-IV034-2025
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 13 Feb 2026 (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.
Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available third-generation EGFR-TKIs. Building on the clinical advantages of this agent and addressing the unmet therapeutic needs in oligometastatic NSCLC, this study aims to conduct a prospective exploration by dynamically monitoring circulating tumor DNA (ctDNA) to guide the application of befotertinib combined with radiotherapy in patients with EGFR mutation-positive oligometastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Befotertinib | Other | Drug: BefotertinibSubjects will receive treatment with Befotertinib. Peripheral blood will be collected 8 weeks (±7 days) later for ctDNA testing. Those who test positive for ctDNA will undergo treatment intensification with Befotertinib combined with radiotherapy, while those who test negative will continue with Befotertinib monotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18-75 years at the time of signing the informed consent form, both males and females are eligible;
- Histologically confirmed newly diagnosed or treatment-naïve oligometastatic stage IV NSCLC (AJCC 9th edition) with ≤3 involved organs and ≤5 metastatic lesions. Regional lymph node involvement (regardless of number) is not counted as metastatic sites; non-regional lymph node involvement is classified as a metastatic lesion;
- Presence of an EGFR sensitizing mutation (19Del or 21L858R);
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status 0-1;
Key exclusion criteria (10 listed)
- Small cell lung cancer or non-small cell lung cancer mixed with histologic types such as small cell lung cancer or neuroendocrine carcinoma;
- Confirmed EGFR exon 20 insertion mutation or non-classical mutations such as L861Q, G719X, or S768I;
- Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc.);
- Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or imaging (CT or MRI) findings of brain or leptomeningeal disease at screening (except those with previously treated brain metastases who have been stable and without progression for ≥4 weeks before enrollment, and confirmed by brain MRI, CT, or venography to have no evidence of intracranial hemorrhage);
- Known history of hypersensitivity to the active or inactive excipients of Befotertinib or to drugs with similar chemical structures or classes;
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 |
|---|---|---|
| BefotertinibSubjects will receive treatment with Befotertinib. Peripheral blood will be collected 8 weeks (±7 days) later for ctDNA testing. Those who test positive for ctDNA will undergo treatment intensification with Befotertinib combined with radiotherapy, while those who test negative will continue with Befotertinib monotherapy. | Drug | Befotertinib |
Primary outcome
Progression-Free Survival
Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 mont
Progression-Free Survival is defined as the time from the initiation of treatment until the first documented radiological progression of disease (PD) or death from any cause, whichever occurs first. If a subject has not experienced PD or death by the study cutoff date, or has received other antitumor therapy, the date of the last efficacy assessment before the cutoff date or the start date of other antitumor therapy (whichever is earlier) will be used as the censoring time.
PFS
Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 22 months
Progression-Free Survival (PFS) is defined as the time from the initiation of treatment until the first documented radiological progression of disease (PD) or death from any cause, whichever occurs first. If a subject has not experienced PD or death by the study cutoff date, or has received other antitumor therapy, the date of the last efficacy assessment before the cutoff date or the start date of other antitumor therapy (whichever is earlier) will be used as the censoring time.
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Befotertinib in people with Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination, run by Hebei Medical University Fourth Hospital 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 22 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Feb 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 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 Zhou Zhiguo Zhou (0086-0311-86095628, chenk777@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 mont). 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 13 Feb 2026.