Advanced Non-small Cell Lung Cancer (NSCLC)Phase 2BE-MASTERNCT07709585
Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients
A Phase 2 study testing Befotinib and Pemetrexed + Cisplatin /Carboplatin in people with Advanced Non-small Cell Lung Cancer (NSCLC) and EGFR Exon 19 Deletion Mutation, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation, EGFR Exon 21 Mutation
- What is being tested?
- Befotinib and Pemetrexed + Cisplatin /Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2026to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
- Age ≥18 years, any gender.
- Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
- No prior systemic anti-tumor therapy.
- ECOG performance status 0-2.
- Expected survival ≥12 weeks.
Show all 16Show fewer
- Able to swallow oral study medication.
- At least one measurable lesion per RECIST 1.1 criteria.
- Adequate organ function as defined below:
- Absolute neutrophil count ≥1.5 × 10^9/L;
- Platelet count ≥100 × 10^9/L;
- Hemoglobin ≥9 g/dL (transfusion allowed);
- Total bilirubin ≤1.5 × ULN;
- ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastasis);
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥45 mL/min by Cockcroft-Gault formula if creatinine >1.5 × ULN.
- Fertile men and women agree to effective contraception during study treatment and for specified time after last dose.
Who cannot join
- Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.
- Participated in another investigational drug trial within 4 weeks prior to first study drug; major surgery within 4 weeks; unhealed wound, active ulcer or fracture; radiotherapy within 2 weeks without recovery.
- Severe cardiovascular disease: QTcF ≥450 ms or clinically significant ECG abnormality; uncontrolled hypertension (SBP>160 mmHg or DBP>100 mmHg); congestive heart failure, cardiomyopathy, arrhythmia requiring intervention, unstable angina, myocardial infarction, stroke or TIA within 6 months prior to treatment.
- Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease.
- Active hemorrhage, clinically significant hemoptysis, high thromboembolic risk or prior severe thromboembolic events unsuitable for study treatment.
Show all 10Show fewer
- Renal dysfunction with creatinine clearance <45 mL/min; prior intolerable toxicity to pemetrexed; severe hypersensitivity to pemetrexed or its excipients.
- Positive serum pregnancy test within 7 days before treatment, pregnant or breastfeeding women; fertile subjects refusing contraception during study and 3 months after last dose.
- Known severe hypersensitivity to befotertinib, cisplatin, carboplatin or their excipients.
- Any other medical, metabolic, physical or lab abnormality that may compromise subject safety or interfere with study results per investigator judgment.
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
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Xiaoshu Chai, MD, chaixiaoshu@126.com
About this study
This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.
- Conditions
- Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation, EGFR Exon 21 Mutation, EGFR Exon 21 L858R Mutation
- Being tested
- Befotinib, Pemetrexed + Cisplatin /Carboplatin
- Keywords
- EGFR sensitive mutation, Minimal Residual Disease, MRD dynamic monitoring, Befotinib, Advanced Non-small Cell Lung Cancer, Targeted therapy plus chemotherapy
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BefotinibDrug
Oral administration, initial dose 75 mg once daily; dose adjusted to 100 mg once daily based on safety and clinical benefit. Used as induction, single-agent maintenance, or combined with chemotherapy.
Pemetrexed + Cisplatin /CarboplatinDrug
This is induction combination chemotherapy for MRD-positive patients after initial befotinib monotherapy. Pemetrexed at 500 mg/m² is given intravenously on Day 1 of each 21-day cycle, combined with either Cisplatin (75 mg/m² IV Day 1) or Carboplatin (AUC 5 IV Day 1) at investigator's discretion based on patient renal function and tolerability, for up to 4 cycles. Standard premedication with folic acid, vitamin B12 and dexamethasone is administered per pemetrexed prescribing guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Befotertinib with chemotherapy guided by dynamic MRD monitoring | Experimental | All participants receive oral befotertinib 75 mg once daily for 3 weeks as induction therapy, followed by MRD detection. Treatment is adjusted dynamically based on serial MRD results: MRD-positive patients get 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; MRD-negative patients continue single-agent befotertinib. Subsequent MRD tests every 12 weeks guide treatment adjustment: patients who have not previously received pemetrexed
-platinum chemotherapy and convert to MRD-positive will receive 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; patients who have previously received pemetrexed-platinum chemotherapy will receive single agent befotertinib if MRD-negative or befotertinib plus pemetrexed maintenance if MRD-positive.Treatment cycles are 21 days, continued until disease progression, intolerable toxicity, withdrawal of consent or death. Receives: Drug: Befotinib; Drug: Pemetrexed + Cisplatin /Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from first dose of study treatment to first radiographically confirmed isease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.
Secondary outcomes (4)
Median Overall Survival (OS)
Defined as the time from first dose of study treatment to death from any cause.
Measured: Including at least 24 months of follow-up after the last participant is enrolled.Participants lost to follow-up will be censored at the last date they were known to be alive.
Objective response rate (ORR)
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1.
Measured: including at least 24 months of follow-up after the last participant is enrolled.
Disease control rate (DCR)
defined as the proportion of participants achieving confirmed complete response (CR), partial response (PR) or stable disease (SD) per RECIST version 1.1.
Measured: including at least 24 months of follow-up after the last participant is enrolled.
Time to intolerable toxicity
Defined as the time from the first dose of study treatment to the first occurrence of treatment-related intolerable adverse event leading to permanent discontinuation of study therapy.
Measured: Including at least 24 months of follow-up after the last participant is enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start5 Jul 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung Cancer (NSCLC)Studies 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
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Sichuan Cancer Hospital and Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Zhu Yanjuan, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Xiaoshu Chai, MD, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709585
- Sponsor's protocol ID
- ZF2026-214
- Acronym
- BE-MASTER
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients
- ClinicalTrials.gov ID
- NCT07709585
- Acronym / sponsor ID
- BE-MASTER / ZF2026-214
- Conditions
- Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation, EGFR Exon 21 Mutation, EGFR Exon 21 L858R Mutation
- Keywords
- EGFR sensitive mutation, Minimal Residual Disease, MRD dynamic monitoring, Befotinib, Advanced Non-small Cell Lung Cancer, Targeted therapy plus chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Chest Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Sichuan Cancer Hospital and Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 16 Jul 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.
This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Befotertinib with chemotherapy guided by dynamic MRD monitoring | Experimental | Drug: Befotinib, Drug: Pemetrexed + Cisplatin /CarboplatinAll participants receive oral befotertinib 75 mg once daily for 3 weeks as induction therapy, followed by MRD detection. Treatment is adjusted dynamically based on serial MRD results: MRD-positive patients get 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; MRD-negative patients continue single-agent befotertinib. Subsequent MRD tests every 12 weeks guide treatment adjustment: patients who have not previously received pemetrexed -platinum chemotherapy and convert to MRD-positive will receive 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; patients who have previously received pemetrexed-platinum chemotherapy will receive single agent befotertinib if MRD-negative or befotertinib plus pemetrexed maintenance if MRD-positive.Treatment cycles are 21 days, continued until disease progression, intolerable toxicity, withdrawal of consent or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
- Age ≥18 years, any gender.
- Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
- No prior systemic anti-tumor therapy.
- ECOG performance status 0-2.
Key exclusion criteria (10 listed)
- Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.
- Participated in another investigational drug trial within 4 weeks prior to first study drug; major surgery within 4 weeks; unhealed wound, active ulcer or fracture; radiotherapy within 2 weeks without recovery.
- Severe cardiovascular disease: QTcF ≥450 ms or clinically significant ECG abnormality; uncontrolled hypertension (SBP>160 mmHg or DBP>100 mmHg); congestive heart failure, cardiomyopathy, arrhythmia requiring intervention, unstable angina, myocardial infarction, stroke or TIA within 6 months prior to treatment.
- Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease.
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 |
|---|---|---|
| BefotinibOral administration, initial dose 75 mg once daily; dose adjusted to 100 mg once daily based on safety and clinical benefit. Used as induction, single-agent maintenance, or combined with chemotherapy. | Drug | Befotertinib with chemotherapy guided by dynamic MRD monitoring |
| Pemetrexed + Cisplatin /CarboplatinThis is induction combination chemotherapy for MRD-positive patients after initial befotinib monotherapy. Pemetrexed at 500 mg/m² is given intravenously on Day 1 of each 21-day cycle, combined with either Cisplatin (75 mg/m² IV Day 1) or Carboplatin (AUC 5 IV Day 1) at investigator's discretion based on patient renal function and tolerability, for up to 4 cycles. Standard premedication with folic acid, vitamin B12 and dexamethasone is administered per pemetrexed prescribing guidelines. | Drug | Befotertinib with chemotherapy guided by dynamic MRD monitoring |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.
Time from first dose of study treatment to first radiographically confirmed isease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
4 secondary outcomes
Median Overall Survival (OS)
Time frame: Including at least 24 months of follow-up after the last participant is enrolled.Participants lost to follow-up will be censored at the last date they were known to be alive.
Objective response rate (ORR)
Time frame: including at least 24 months of follow-up after the last participant is enrolled.
Disease control rate (DCR)
Time frame: including at least 24 months of follow-up after the last participant is enrolled.
Time to intolerable toxicity
Time frame: Including at least 24 months of follow-up after the last participant is enrolled.
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Not yet recruitingPhase 3
Reduced-Dose vs Standard-Dose Thoracic Radiotherapy After Induction Chemoimmunotherapy in Older or Frail Stage III NSCLC
Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 1
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Advanced Solid Tumor
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.
Xiaoshu Chai, MD principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
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 Befotinib and Pemetrexed + Cisplatin /Carboplatin in people with Advanced Non-small Cell Lung Cancer (NSCLC) and EGFR Exon 19 Deletion Mutation, run by Guangzhou University of Traditional Chinese Medicine 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 16 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 16 Jul 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 Xiaoshu Chai, MD (+8613570301605, chaixiaoshu@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 (PFS) (time frame: Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.). 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 16 Jul 2026.