Actively Recruiting
A Randomized Phase III Study of BL-M07D1 Versus Pembrolizumab-Platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-17
440
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BL-M07D1 compared to pembrolizumab-platinum chemotherapy as a first-line treatment in patients with HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer. This phase III, randomized, open-label, multicenter study focuses on adults aged 18 to 75 years who have confirmed HER2 mutations in their cancer and measurable tumors. Participants receive either BL-M07D1 or pembrolizumab combined with pemetrexed and carboplatin or cisplatin, administered by intravenous infusion every three weeks in treatment cycles. Those benefiting from treatment may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons for stopping treatment occur. Throughout the study, researchers will monitor participants for up to approximately 24 months, assessing progression-free survival as the primary outcome. Secondary measures include overall survival, response rates, disease control, duration of response, treatment-related adverse events, and the presence of anti-drug antibodies. Participants will undergo various tests and evaluations to track these outcomes and ensure safety during the study period.
CONDITIONS
Brief Title
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow study rules
- Aged 18 to 75 years, any gender
- Expected to live at least 12 weeks
- Confirmed advanced or metastatic non-squamous non-small cell lung cancer
- Confirmed HER2 functional mutation by central lab
- Provided recent tumor tissue for biomarker testing
- At least one measurable tumor lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Recovery to Grade 1 or less from previous anti-tumor treatment side effects
- Met required organ function levels
- Premenopausal women must have negative pregnancy test within 7 days before treatment and not be breastfeeding
- All patients must use effective contraception during treatment and for 7 months after
You will not qualify if you...
- Surgery, radical radiotherapy, immunotherapy, or similar treatments within 4 weeks before first dose
- Non-small cell carcinoma with small cell or sarcomatoid components
- Presence of other targetable driver gene mutations for NSCLC
- Previous HER2-targeted therapy or ADC drugs with camptothecin derivatives
- Severe heart or brain vascular disease within 6 months before screening
- Severe lung diseases impairing lung function
- History or current diagnosis of interstitial lung disease requiring steroids
- Certain heart rhythm problems or arrhythmias
- Other primary cancers diagnosed within 5 years before first dose
- Recent deep vein thrombosis within 14 days before screening
- Poorly controlled high blood pressure
- Central nervous system metastases or spinal cord compression
- Severe allergies to study drug components
- History of stem cell or organ transplantation
- Positive HIV or active hepatitis B/C infection or liver cirrhosis
- Severe infections within 4 weeks before investigational drug use
- Significant or uncontrolled fluid accumulation in chest or abdomen
- Systemic corticosteroid use above 10 mg/day prednisone equivalent before randomization
- Severe neurological or psychiatric disorders
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Certain intestinal diseases or chronic diarrhea
- Receipt or planned receipt of live vaccines within 28 days before first dose
- Other severe health conditions, poor compliance, or factors making study participation risky or unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive intravenous infusions of either BL-M07D1 or Pembrolizumab combined with platinum chemotherapy drugs every 3 weeks. Treatment continues for multiple cycles until disease progression, intolerable toxicity, or other reasons lead to discontinuation.
Visits every 3 weeks for each treatment cycle
Duration - Up to approximately 24 months after treatment
Participants are monitored for up to approximately 24 months to assess progression-free and overall survival, treatment response, and safety after treatment ends.
Periodic visits during follow-up for assessments
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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