EGFRPhase 2NCT06755684
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer
A Phase 2 study testing Befotertinib combined Bevacizumab and Befotertinib combined platinum-based double chemotherapy in people with EGFR and Non-Small Cell Lung Cancer, run by Peng Zhang at 1 site in China.
Trial summary
This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR, Non-Small Cell Lung Cancer, Locally Advanced Non-Small Cell Lung Cancer
- What is being tested?
- Befotertinib combined Bevacizumab and Befotertinib combined platinum-based double chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2024to 31 Dec 2028
- 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
- NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
- At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
- No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
- With the feasibility to receive radical surgery ;
- Good lung function that could tolerate surgical treatment;
- Aged 18-75 years;
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- At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
- Other major organs shall function well (liver, kidney, blood system, etc.):
- ECOG PS score shall be 0-1;
- The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
- The patient shall sign the Informed Consent Form.
Who cannot join
- The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
- The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
- The patient is a carrier of HIV;
- The patient has had or is currently suffering from interstitial lung disease;
- The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
- The patient is allergic to befotertinib or its any excipients;
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- The patient is allergic to bevacizumab or its any excipients;
- The patient is allergic to platinum-based double chemotherapy or its any excipients;
- The female patient is in pregnancy or lactation period;
- There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yue Liu contact
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Yue Liu, 18831402353, 18831402353@163.com
About this study
Official title: Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial
This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation
- Conditions
- EGFR, Non-Small Cell Lung Cancer, Locally Advanced Non-Small Cell Lung Cancer, Pemetrexed, Carboplatin, Bevacizumab
- Being tested
- Befotertinib combined Bevacizumab, Befotertinib combined platinum-based double chemotherapy
- Keywords
- EGFR-TKI, NSCLC, Chemotherapy, Bevacizumab, Locally advanced non-small cell lung cancer
- 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.
Befotertinib combined BevacizumabDrug
Befotertinib combined Bevacizumab
Befotertinib combined platinum-based double chemotherapyDrug
Befotertinib combined platinum-based double chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Befotertinib combined Bevacizumab | Experimental | Befotertinib combined Bevacizumab Receives: Drug: Befotertinib combined Bevacizumab |
| Befotertinib combined platinum-based double chemotherapy | Experimental | Befotertinib combined platinum-based double chemotherapy Receives: Drug: Befotertinib combined platinum-based double chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Measured: up to 4 months
Secondary outcomes (8)
Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Measured: Up to 4 months
Progression-free survival (PFS)
It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Measured: up to 60 months
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 60 months
Disease-free survival (DFS)
It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Measured: up to 60 months
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: up to 60 months
R0 rate
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Measured: up to 4 months
adverse event (AE) rate
It is defined as the frequency of adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Measured: up to 4 months
Complete Pathological response (CPR)
CPR is defined as the proportion of participants who have achieved complete pathologic response (on routine hematoxylin and eosin staining, tumors with no viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start7 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFRStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755684
- Sponsor's protocol ID
- LungMate-021
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06755684
- Acronym / sponsor ID
- LungMate-021
- Conditions
- EGFR, Non-Small Cell Lung Cancer, Locally Advanced Non-Small Cell Lung Cancer, Pemetrexed, Carboplatin, Bevacizumab
- Keywords
- EGFR-TKI, NSCLC, Chemotherapy, Bevacizumab, Locally advanced non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peng ZhangUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jan 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 study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Befotertinib combined Bevacizumab | Experimental | Drug: Befotertinib combined BevacizumabBefotertinib combined Bevacizumab |
| Befotertinib combined platinum-based double chemotherapy | Experimental | Drug: Befotertinib combined platinum-based double chemotherapyBefotertinib combined platinum-based double chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
- At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
- No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
- With the feasibility to receive radical surgery ;
- Good lung function that could tolerate surgical treatment;
Key exclusion criteria (10 listed)
- The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
- The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
- The patient is a carrier of HIV;
- The patient has had or is currently suffering from interstitial lung disease;
- The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before 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 |
|---|---|---|
| Befotertinib combined BevacizumabBefotertinib combined Bevacizumab | Drug | Befotertinib combined Bevacizumab |
| Befotertinib combined platinum-based double chemotherapyBefotertinib combined platinum-based double chemotherapy | Drug | Befotertinib combined platinum-based double chemotherapy |
Primary outcome
Major pathologic response (MPR)
Time frame: up to 4 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
8 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 4 months
Progression-free survival (PFS)
Time frame: up to 60 months
Event-free survival (EFS)
Time frame: Up to 60 months
Disease-free survival (DFS)
Time frame: up to 60 months
Overall survival (OS)
Time frame: up to 60 months
R0 rate
Time frame: up to 4 months
adverse event (AE) rate
Time frame: up to 4 months
Complete Pathological response (CPR)
Time frame: Up to 4 months
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Yue Liu contact
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 combined Bevacizumab and Befotertinib combined platinum-based double chemotherapy in people with EGFR and Non-Small Cell Lung Cancer, run by Peng Zhang 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 11 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: looking for participants now, as of the sponsor's last update on 6 Jan 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 Peng Zhang (02165115006, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) (time frame: up to 4 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 6 Jan 2025.