Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2Phase 4BEST2NCT07900243
A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
A Phase 4 study testing Befotertinib and Icotinib in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2, run by Zhou Chengzhi.
Trial summary
This study is a multicenter, randomized, open-label, parallel-controlled clinical trial. It is designed to evaluate the efficacy and safety of Befotertinib versus Icotinib as first-line treatment in patients with previously untreated EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
- What is being tested?
- Befotertinib and Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Dec 2030
- Phase
- Phase 4
- 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
- Voluntarily sign written informed consent and be able to understand and comply with the protocol requirements.
- Age ≥18 years at the time of signing informed consent.
- Histologically or cytologically confirmed locally advanced (AJCC 9th edition stage IIIB and IIIC) or metastatic non-small cell lung adenocarcinoma (AJCC 9th edition stage IV), not suitable for radical surgery or radiotherapy. If the patient's performance status is assessed as unsuitable for obtaining biological samples, and the ECOG score is ≥3, a clinical diagnosis is acceptable.
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; must have EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation, either alone or coexisting with other EGFR site mutations). For patients who have received local treatment more than 2 weeks prior, if the lesions within the local treatment field are non-target lesions, the patient may be enrolled.
- Note: If a patient had previously completed radical surgery and adjuvant therapy for early-stage NSCLC but later experienced recurrence or metastasis, the patient may still be enrolled, provided that adjuvant therapy was completed more than 6 months before the first dose in this study.
- ECOG performance status score ≥2.
- Expected survival of at least 12 weeks.
Who cannot join
- Concurrent other malignancies (except cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, and papillary thyroid carcinoma).
- Prior use of any systemic anti-tumor therapy for locally advanced or metastatic NSCLC, including systemic chemotherapy, immunotherapy, biotherapy, or targeted therapy.
- Major surgery within 4 weeks before study drug treatment, except minor surgery judged by the investigator not to affect participation in the trial (e.g., tooth extraction); or planned major surgery during the study.
- Significant worsening of symptoms or signs within 2 weeks before screening (e.g., massive pleural effusion within 2 weeks before screening; patients may be considered for screening after the effusion is controlled), and the investigator judges the patient unsuitable for the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a multicenter, randomized, open-label, parallel-controlled clinical trial. It is designed to evaluate the efficacy and safety of Befotertinib versus Icotinib as first-line treatment in patients with previously untreated EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer with ECOG score ≥2.
- Being tested
- Befotertinib, Icotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BefotertinibDrug
befortertinib
IcotinibDrug
Icotinib
| Study group | Role | What they receive |
|---|---|---|
| befotertinib | Experimental | Not described Receives: Drug: Befotertinib |
| Icotinib | Active comparator | Not described Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 9 weeks
Secondary outcomes (1)
ORR
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900243
- Sponsor's protocol ID
- ES-2026-098-03
- Acronym
- BEST2
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
- ClinicalTrials.gov ID
- NCT07900243
- Acronym / sponsor ID
- BEST2 / ES-2026-098-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Oct 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 study is a multicenter, randomized, open-label, parallel-controlled clinical trial. It is designed to evaluate the efficacy and safety of Befotertinib versus Icotinib as first-line treatment in patients with previously untreated EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer with ECOG score ≥2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| befotertinib | Experimental | Drug: Befotertinib |
| Icotinib | Active comparator | Drug: Icotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign written informed consent and be able to understand and comply with the protocol requirements.
- Age ≥18 years at the time of signing informed consent.
- Histologically or cytologically confirmed locally advanced (AJCC 9th edition stage IIIB and IIIC) or metastatic non-small cell lung adenocarcinoma (AJCC 9th edition stage IV), not suitable for radical surgery or radiotherapy. If the patient's performance status is assessed as unsuitable for obtaining biological samples, and the ECOG score is ≥3, a clinical diagnosis is acceptable.
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; must have EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation, either alone or coexisting with other EGFR site mutations). For patients who have received local treatment more than 2 weeks prior, if the lesions within the local treatment field are non-target lesions, the patient may be enrolled.
- Note: If a patient had previously completed radical surgery and adjuvant therapy for early-stage NSCLC but later experienced recurrence or metastasis, the patient may still be enrolled, provided that adjuvant therapy was completed more than 6 months before the first dose in this study.
Key exclusion criteria (4 listed)
- Concurrent other malignancies (except cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, and papillary thyroid carcinoma).
- Prior use of any systemic anti-tumor therapy for locally advanced or metastatic NSCLC, including systemic chemotherapy, immunotherapy, biotherapy, or targeted therapy.
- Major surgery within 4 weeks before study drug treatment, except minor surgery judged by the investigator not to affect participation in the trial (e.g., tooth extraction); or planned major surgery during the study.
- Significant worsening of symptoms or signs within 2 weeks before screening (e.g., massive pleural effusion within 2 weeks before screening; patients may be considered for screening after the effusion is controlled), and the investigator judges the patient unsuitable for the trial.
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 |
|---|---|---|
| Befotertinibbefortertinib | Drug | befotertinib |
| IcotinibIcotinib | Drug | Icotinib |
Primary outcome
PFS
Time frame: 9 weeks
1 secondary outcome
ORR
Time frame: 9 weeks
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Befotertinib and Icotinib in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2, run by Zhou Chengzhi.
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 7 inclusion and 4 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Chengzhi zhou Zhou (8613560351186, doctorzcz@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 9 weeks). 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 28 Oct 2026.