Actively Recruiting
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-17
440
Participants Needed
1
Research Sites
113 weeks
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
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
Official 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...
- Provide signed informed consent and follow study rules
- Age between 18 and 75 years at consent
- Life expectancy of at least 12 weeks
- Confirmed advanced or metastatic non-squamous non-small cell lung cancer
- HER2 functional mutation confirmed by central lab
- Provide recent tumor tissue for biomarker testing
- Have at least one measurable tumor lesion
- ECOG performance status of 0 or 1
- Recover from prior treatment side effects to Grade 1 or less
- Meet organ function requirements
- For premenopausal women, negative pregnancy test within 7 days before treatment and not breastfeeding
- All patients must use effective contraception during treatment and for 7 months after
You will not qualify if you...
- Surgery, radical radiotherapy, or immunotherapy within 4 weeks or 5 drug half-lives before first dose
- Non-small cell carcinoma with small cell or sarcomatoid components
- Other driver gene mutations with approved targeted therapies for NSCLC
- Prior HER2-targeted or camptothecin-based antibody drug conjugate treatment
- Severe heart or brain blood vessel diseases within 6 months before screening
- Severe lung diseases impairing function
- Interstitial lung disease or pneumonia requiring steroids or current diagnosis
- Serious heart rhythm problems
- Other primary cancers diagnosed within 5 years before first dose
- New deep vein thrombosis within 14 days before screening
- Poorly controlled high blood pressure
- Brain metastases, carcinomatous meningitis, or spinal cord compression
- Severe allergies to study drug components
- History of stem cell or organ transplant
- Positive HIV antibody or active hepatitis B/C or liver cirrhosis
- Severe infections within 4 weeks before first dose
- Significant or uncontrolled fluid buildup in body cavities
- Use of systemic corticosteroids over 10 mg prednisone equivalent before randomization
- Severe neurological or psychiatric disorders
- Significant bleeding or bleeding risk within 4 weeks before consent
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Planned or received live vaccines within 28 days before first dose
- Other serious health or lab abnormalities or factors affecting study safety or results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
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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