NSCLC (Non-small Cell Lung Cancer)Phase 2NCT06863506
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
A Phase 2 study testing befotertinib in people with NSCLC (Non-small Cell Lung Cancer), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- befotertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Dec 2027
- 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
- Age ≥18 years, ECOG performance status 0-2
- Histologically confirmed locally advanced/metastatic NSCLC
- Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)
- No prior EGFR-TKI therapy
- Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1
Who cannot join
- Previous EGFR-TKI treatment
- Active CNS metastases (asymptomatic patients with stable lesions allowed)
- Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months)
- Active HBV/HCV/HIV infection
- Pregnancy or lactation
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, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Xia Yang, +86 18868439669, yxia@zju.edu.cn
About this study
Official title: Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients
This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations.
The study comprises two independent cohorts:
Read more
Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation
Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- 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
Befotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| G719X, L861Q, or S768I) | Experimental | Patients with EGFR uncommon mutations (G719X, L861Q, or S768I) Receives: Drug: befotertinib |
| exon 20 insertion | Experimental | Patients with EGFR exon 20 insertion mutations Receives: Drug: befotertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) assessed by RECIST 1.1.
Measured: From enrollment until treatment discontinuation (up to 24 months)
Secondary outcomes (4)
progression-free survival (PFS)
Measured: From first dose to disease progression or death (assessed up to 36 months)
Disease control rate (DCR)
Measured: From enrollment until treatment discontinuation (up to 24 months)
duration of response (DoR)
Measured: From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.
overall survival（OS）
Measured: From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou University, Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University, Taizhou Hospital, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Li Wen, Prof., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineXia Yang, Prof., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863506
- Sponsor's protocol ID
- 2024-0190
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06863506
- Acronym / sponsor ID
- 2024-0190
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhengzhou University, Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University, Taizhou Hospital, West China Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Mar 2025 (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 prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations.
The study comprises two independent cohorts:
Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation
Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G719X, L861Q, or S768I) | Experimental | Drug: befotertinibPatients with EGFR uncommon mutations (G719X, L861Q, or S768I) |
| exon 20 insertion | Experimental | Drug: befotertinibPatients with EGFR exon 20 insertion mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years, ECOG performance status 0-2
- Histologically confirmed locally advanced/metastatic NSCLC
- Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)
- No prior EGFR-TKI therapy
- Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1
Key exclusion criteria (5 listed)
- Previous EGFR-TKI treatment
- Active CNS metastases (asymptomatic patients with stable lesions allowed)
- Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months)
- Active HBV/HCV/HIV infection
- Pregnancy or lactation
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 |
|---|---|---|
| befotertinibBefotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. | Drug | G719X, L861Q, or S768I), exon 20 insertion |
Primary outcome
Objective response rate (ORR) assessed by RECIST 1.1.
Time frame: From enrollment until treatment discontinuation (up to 24 months)
4 secondary outcomes
progression-free survival (PFS)
Time frame: From first dose to disease progression or death (assessed up to 36 months)
Disease control rate (DCR)
Time frame: From enrollment until treatment discontinuation (up to 24 months)
duration of response (DoR)
Time frame: From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.
overall survival（OS）
Time frame: From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up
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 7 Mar 2025.
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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.
Li Wen, Prof. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Xia Yang, Prof. principal investigator
Second Affiliated Hospital, Zhejiang University, School of 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 befotertinib in people with NSCLC (Non-small Cell Lung Cancer), run by Second Affiliated Hospital, Zhejiang University, School of 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 5 inclusion and 5 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 7 Mar 2025. 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 Xia Yang (+86 18868439669, yxia@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) assessed by RECIST 1.1. (time frame: From enrollment until treatment discontinuation (up to 24 months)). 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 7 Mar 2025.