Non-squamous Non-small Cell Lung CancerPhase 3NCT07178795
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
A Phase 3 study testing BL-M07D1, Pembrolizumab and Pemetrexed in people with Non-squamous Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous 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-squamous Non-small Cell Lung Cancer
- What is being tested?
- BL-M07D1, Pembrolizumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2025to Dec 2027
- Phase
- Phase 3
- 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 protocol requirements;
- Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;
- Expected survival time ≥12 weeks;
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;
- HER2 functional mutation confirmed by a central laboratory;
- Provide the most recent tumor tissue meeting the requirements for biomarker testing by the central laboratory;
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- Must have at least one measurable target lesion as defined by RECIST v1.1;
- ECOG performance status score of 0 or 1;
- Toxicity from previous anti-tumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- Organ function levels must meet the requirements;
- For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days prior to the start of treatment, and the serum pregnancy test must be negative. They must not be breastfeeding. All enrolled patients (regardless of gender) should take adequate and highly effective contraceptive measures throughout the treatment period and for 7 months after the end of treatment.
Who cannot join
- Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
- Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;
- Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months prior to screening;
- Concurrent pulmonary diseases leading to severe impairment of lung function;
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- History of ILD/interstitial pneumonia requiring steroid treatment or current diagnosis of ILD/interstitial pneumonia;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- Diagnosis of other primary malignancies within 5 years prior to the first dose;
- Newly developed deep vein thrombosis within 14 days prior to screening;
- Hypertension poorly controlled by antihypertensive medications;
- Patients with central nervous system (CNS) metastases, carcinomatous meningitis (leptomeningeal metastases), and/or spinal cord compression;
- Patients with a history of severe allergies to any excipients or components of the investigational drug;
- History of autologous or allogeneic stem cell transplantation or organ transplantation;
- Positive human immunodeficiency virus antibody, active hepatitis B virus infection, liver cirrhosis, or hepatitis C virus infection;
- Occurrence of severe infections within 4 weeks prior to the first use of the investigational drug;
- Patients with significant serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
- Systemic corticosteroid treatment with >10 mg/d prednisone or equivalent prior to randomization;
- Presence of severe neurological or psychiatric disorders;
- Subjects with clinically significant bleeding or obvious bleeding tendencies within 4 weeks prior to signing informed consent;
- Conditions such as intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea;
- Subjects planning to receive or having received live vaccines within 28 days prior to the first dose;
- Presence of other severe physical or laboratory abnormalities, poor compliance, or any other factors that may increase the risk of participation in the study, interfere with study results, or make the patient unsuitable for participation in the study as determined by the investigator.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
About this study
Official title: A Randomized Controlled Phase III Clinical Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- BL-M07D1, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M07D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
PembrolizumabDrug
Administration by intravenous infusion for a cycle of 3 weeks.
PemetrexedDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CarboplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
CisplatinDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M07D1 | Experimental | Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M07D1 |
| Pembrolizumab-platinum chemotherapy | Active comparator | Participants receive Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Secondary outcomes (6)
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start29 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178795
- Sponsor's protocol ID
- BL-M07D1-306
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase III Clinical Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07178795
- Acronym / sponsor ID
- BL-M07D1-306
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Sep 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 trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-M07D1 | Experimental | Drug: BL-M07D1Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
| Pembrolizumab-platinum chemotherapy | Active comparator | Drug: Pembrolizumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: CisplatinParticipants receive Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;
- Expected survival time ≥12 weeks;
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;
- HER2 functional mutation confirmed by a central laboratory;
Key exclusion criteria (23 listed)
- Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
- Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;
- Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months prior to screening;
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-M07D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1 |
| PembrolizumabAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Pembrolizumab-platinum chemotherapy |
| PemetrexedAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Pembrolizumab-platinum chemotherapy |
| CarboplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Pembrolizumab-platinum chemotherapy |
| CisplatinAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | Pembrolizumab-platinum chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
6 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 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 17 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-M07D1, Pembrolizumab and Pemetrexed in people with Non-squamous Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. 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 23 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 17 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.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 approximately 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 17 Nov 2025.