Actively Recruiting
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-20
720
Participants Needed
1
Research Sites
196 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 registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.
CONDITIONS
Official Title
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow study rules
- Age 18 years or older
- Expected survival time of at least 3 months
- Locally advanced non-small cell lung cancer that cannot be removed by surgery or treated with radical radiotherapy
- EGFR sensitive mutations confirmed by tumor tissue or blood test
- Agree to provide tumor tissue samples for testing
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Previous antitumor therapy side effects have returned to grade 1 or less
- No severe heart dysfunction with left ventricular ejection fraction of 50% or higher
- Adequate organ function without recent blood transfusion or colony-stimulating factor use
- Urinary protein level 2+ or less or less than 1000 mg/24h
- 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 6 months after
You will not qualify if you...
- History or evidence of small cell or mixed small/non-small cell lung cancer
- Previous systemic therapy for lung cancer
- Previous treatment with EGFR-TKI drugs
- Radical radiotherapy, major surgery, or large-area radiotherapy within 4 weeks before study start
- Severe heart or cerebrovascular disease history
- Unstable blood clots requiring treatment in past 6 months
- Certain serious heart rhythm problems
- Active cancer diagnosed within past 3 years
- Poorly controlled hypertension despite two medications
- Poor blood sugar control
- History or current interstitial lung disease requiring steroids or significant radiation pneumonitis
- Severe lung disease affecting breathing
- Active brain metastases
- Severe infection within 4 weeks before study
- Large or uncontrolled fluid buildup in chest or abdomen
- Tumor invading large blood vessels
- Serious wounds, ulcers, or broken bones not healed within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks
- History of inflammatory bowel disease or serious bowel conditions
- Allergy to study drug or its components
- History of stem cell transplant
- HIV positive or active hepatitis B or C infection
- Severe neurological or psychiatric illness
- Recent use of other investigational drugs within 4 weeks
- Scheduled for or recently received live vaccine
- Other conditions making participation unsafe 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
Shanghai East Hospital
Shanghai, Shanghai Municipality, 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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