Non-Small Cell Lung CancerPhase 2NCT06951464
A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC
A Phase 2 study testing BL-B01D1 and Almonertinib in people with Non-Small Cell Lung Cancer, run by Sichuan University at 1 site in China.
Trial summary
This is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- BL-B01D1 and Almonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 5 Mar 2029
- 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
- Voluntarily sign the informed consent form and comply with the study protocol requirements.
- Male or female, Age ≥18 years and ≤75 years at the time of signing the informed consent form.
- Diagnosed with stage II-IIIB (according to Version 8 of TNM staging) EGFR-sensitive mutation-positive non-small cell lung cancer (NSCLC) with feasibility or potential feasibility for radical surgery (radical lobectomy + systematic lymph node dissection), and assessed by the investigator as requiring neoadjuvant therapy.
- Adequate pulmonary function to tolerate surgery.
- Must have at least one measurable lesion per RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1.
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- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%.
- Organ function levels must meet the following criteria:
- Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
- Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN, AST and ALT ≤2.5×ULN;
- Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula);
- Albumin ≥30 g/L.
- Coagulation function: International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Urine protein: ≤2+ on dipstick or ≤1000 mg/24h.
- Contraception: Females of childbearing potential or males with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 6 months after the last dose. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
Who cannot join
- Patients who have received previous systemic or local anti-tumor therapy for non-small-cell lung cancer.
- Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment.
- Major surgery (investigator-defined) within 4 weeks before the first dose.
- Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.
- Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications.
- Patients at risk for active autoimmune disease, or with a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes mellitus, hypothyroidism that is stable with hormone-replacement therapy (including that due to autoimmune thyroiditis), psoriasis or vitiligo that does not require systemic treatment, and hypothyroidism that is stable with hormone-replacement therapy.
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- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA copy number > central detection lower limit) or hepatitis C virus infection (HCV antibody positive and HCV-RNA> central detection lower limit).
- Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg).
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, complete left bundle branch block, frequent and uncontrollable arrhythmias, such as atrial fibrillation, atrial flutter, ventricular fibrillation, and ventricular flutter (except transient); h) prolonged QT interval (QTc>450 msec in men or QTc>470 msec in women) at rest (except transient);
- acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular or cerebrovascular event occurring within 6 months before the first dose;
- patients with New York Heart Association (NYHA) functional class ≥II heart failure;
- unstable angina pectoris;
- Patients with a history of cerebral infarction or cerebral hemorrhage within 6 months;
- Previous history of allogeneic stem cell, bone marrow or organ transplantation.
- Patients with a history of allergy to recombinant humanized antibodies or to BL-B01D1 or any excipients of Almonertinib Mesylate Tablets.
- A history of autologous or allogeneic stem cell transplantation.
- Pregnant or lactating women.
- Other circumstances considered by the investigator to be inappropriate for participation in the trial.
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
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Yue Chen, 8602885421606, cy9209@163.com
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer
This is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- BL-B01D1, Almonertinib
- 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.
BL-B01D1Drug
BL-B01D1 (2.2 or 2.5mg/kg) to be administered on Day 1 and Day 8 of every 3-week cycle for 2 cycles.
AlmonertinibDrug
Almonertinib 100mg QD
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1 plus Almonertinib | Experimental | Neoadjuvant BL-B01D1 2.2 or 2.5mg/kg D1D8 Q3W plus Almonertinib 100mg QD Receives: Drug: BL-B01D1; Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery
Measured: Approximately 9-11 weeks after the first dose
Major Pathological Response (MPR)
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
Measured: Approximately 9-11 weeks after the first dose
Secondary outcomes (6)
Objective Response Rate（ORR）
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Measured: Approximately 9-11 weeks after the first dose
Event-free survival (EFS)
An event is defined as documented disease progression that precludes surgery or prevents completion of definitive surgery; recurrence or a new lesion, local or distant (a new primary malignancy, confirmed by pathology if clinically feasible, is not considered to be an EFS event); death due to any cause
Measured: From date of first administration up to approximately 5.5 years after the last patient is administrated
Disease free survival (DFS)
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Measured: From date of first administration up to approximately 3.5 years after the last patient is administrated
Overall Survival (OS)
OS will be defined as the time from the date of first dosing until death due to any cause
Measured: From date of first administration up to approximately 5.5 years after the last patient is administrated
R0 resection rate
R0 resection rate is defined as the proportion of subjects with complete surgical resection with microscopically negative margins (no residual cancer cells at the edges of the excised tissue).
Measured: Approximately 9-11 weeks after the first dose
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
Measured: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Jun 2025
- Primary completion5 May 2027 (estimated)
- Study completion5 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Sichuan University
- Investigators
- Yongsheng Wang, Principal investigator, West China HospitalLunxu Liu, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951464
- Sponsor's protocol ID
- BL-B01D1-206
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chen Y, Mei J, Gao G, Zhang B, Li Y, Peng Z, Li C, Gan F, Pu Q, Liu C, Yang W, Liu L, Wang Y. A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. Transl Lung Cancer Res. 2025 Dec 31;14(12):5527-5534. doi: 10.21037/tlcr-2025-829. Epub 2025 Dec 17.
PubMed 41510386
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06951464
- Acronym / sponsor ID
- BL-B01D1-206
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 Mar 2029 (estimated)
- First posted
- 30 Apr 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 Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1 plus Almonertinib | Experimental | Drug: BL-B01D1, Drug: AlmonertinibNeoadjuvant BL-B01D1 2.2 or 2.5mg/kg D1D8 Q3W plus Almonertinib 100mg QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily sign the informed consent form and comply with the study protocol requirements.
- Male or female, Age ≥18 years and ≤75 years at the time of signing the informed consent form.
- Diagnosed with stage II-IIIB (according to Version 8 of TNM staging) EGFR-sensitive mutation-positive non-small cell lung cancer (NSCLC) with feasibility or potential feasibility for radical surgery (radical lobectomy + systematic lymph node dissection), and assessed by the investigator as requiring neoadjuvant therapy.
- Adequate pulmonary function to tolerate surgery.
- Must have at least one measurable lesion per RECIST v1.1 criteria.
Key exclusion criteria (19 listed)
- Patients who have received previous systemic or local anti-tumor therapy for non-small-cell lung cancer.
- Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment.
- Major surgery (investigator-defined) within 4 weeks before the first dose.
- Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.
- Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications.
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 |
|---|---|---|
| BL-B01D1BL-B01D1 (2.2 or 2.5mg/kg) to be administered on Day 1 and Day 8 of every 3-week cycle for 2 cycles. | Drug | BL-B01D1 plus Almonertinib |
| AlmonertinibAlmonertinib 100mg QD | Drug | BL-B01D1 plus Almonertinib |
Primary outcome
Pathological complete response (pCR)
Time frame: Approximately 9-11 weeks after the first dose
Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery
Major Pathological Response (MPR)
Time frame: Approximately 9-11 weeks after the first dose
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
6 secondary outcomes
Objective Response Rate（ORR）
Time frame: Approximately 9-11 weeks after the first dose
Event-free survival (EFS)
Time frame: From date of first administration up to approximately 5.5 years after the last patient is administrated
Disease free survival (DFS)
Time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated
Overall Survival (OS)
Time frame: From date of first administration up to approximately 5.5 years after the last patient is administrated
R0 resection rate
Time frame: Approximately 9-11 weeks after the first dose
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
Time frame: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery
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 23 Jul 2025.
- Derived from this study: PubMed 41510386Chen Y, Mei J, Gao G, Zhang B, Li Y, Peng Z, Li C, Gan F, Pu Q, Liu C, Yang W, Liu L, Wang Y. A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. Transl Lung Cancer Res. 2025 Dec 31;14(12):5527-5534. doi: 10.21037/tlcr-2025-829. Epub 2025 Dec 17.
- Individual participant dataSharing planned: Yes
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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.
Yongsheng Wang principal investigator
West China Hospital
Lunxu Liu principal investigator
West China Hospital
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 BL-B01D1 and Almonertinib in people with Non-Small Cell Lung Cancer, run by Sichuan University 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 15 inclusion and 19 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 23 Jul 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 Yue Chen, PhD (86（028）85421606, cy9209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: Approximately 9-11 weeks after the first dose). 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?
On the ClinicalTrials.gov record for NCT06951464, which also lists 1 linked publication.
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 23 Jul 2025.