Actively Recruiting
LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-06-28
50
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.
CONDITIONS
Official Title
LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any trial procedures
- Be 18 years of age or older
- Have locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC confirmed by biopsy, not suitable for surgery or curative radiotherapy/chemotherapy
- Do not have gene mutations in EGFR, ALK fusion oncogene, or ROS1; patients with other mutations lacking approved targeted therapies may participate
- For Cohort 1: Developed resistance to PD-1 inhibitors after at least 6 months of treatment response; for Cohort 2: No prior systemic anti-tumor treatment for advanced disease or progression more than 6 months after prior adjuvant/neoadjuvant therapy
- Have at least one measurable tumor lesion per RECIST 1.1
- Have an estimated life expectancy of 3 months or more
- Have an ECOG performance status score of 0 or 1
- Provide tumor tissue samples for biomarker testing or agree to biopsy during screening
- Have adequate blood counts (neutrophils, platelets, hemoglobin)
- Have liver function within specified limits (bilirubin, AST, ALT)
- Have kidney function with serum creatinine within limits
- Have coagulation function within limits (INR or PT)
- Women of childbearing potential must have a negative pregnancy test and use reliable contraception; men must use condoms during and 30 days after the trial
- Agree to comply with regular follow-up and trial requirements
You will not qualify if you...
- Prior use of CCR8 drugs or other unapproved investigational treatments
- Known intolerance to PD-1 inhibitor therapy
- Received any approved systemic anti-cancer therapy or immunostimulants within 28 days before starting study treatment
- Used traditional Chinese medicine or immunomodulatory drugs with anti-tumor effects within 2 weeks before dosing
- History of allergic reactions to any study drug components
- Known brain metastases unless stable as judged by investigator
- Active bleeding, diverticulitis, abscess, bowel obstruction, or peritoneal metastasis needing intervention
- Uncontrolled pleural effusion or ascites
- Tumor causing compression of vital organs or major vessels
- Severe comorbidities such as recent serious pulmonary or cardiac events, thrombosis, embolism, or ischemia
- Use of systemic corticosteroids or immunosuppressive agents within 2 weeks prior to enrollment, except certain topical or inhaled forms
- History of autoimmune diseases except stable autoimmune hypothyroidism or type 1 diabetes under control
- Active systemic infections including tuberculosis, hepatitis B or C, or HIV
- Psychiatric disorders or substance abuse affecting compliance
- Recent full therapeutic dose anticoagulants or thrombolytics (prophylactic use allowed)
- Any other conditions or abnormalities interfering with trial participation or outcomes as determined 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 Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
L
Li Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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