Actively Recruiting
Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-09-19
148
Participants Needed
5
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.
CONDITIONS
Official Title
Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC that is histologically confirmed as inoperable and unsuitable for radical radiotherapy and chemotherapy
- Aged between 18 and 75 years old with an ECOG performance status of 0-1 and expected survival of at least 3 months
- Have at least one measurable lesion based on RECIST 1.1 criteria
- Experienced disease progression after first-line treatment with immune checkpoint inhibitors plus platinum-based chemotherapy
- Able to provide tumor tissue samples for PD-L1 testing, either archived or fresh within 12 months before randomization
- For non-squamous NSCLC, must test negative for EGFR sensitive mutations, ALK fusion, and ROS1 fusion oncogenes; special stratification for adenosquamous carcinoma
- Have good main organ function
- Women of childbearing age and men agree to use effective contraception during and for 6 months after the study; negative pregnancy test within 7 days before enrollment
- Voluntarily consent to participate and comply with study requirements
You will not qualify if you...
- Presence of untreated or symptomatic central nervous system metastases not meeting specific criteria
- Active malignant tumors within 2 years prior to randomization
- Central type squamous cell carcinoma with cavitation near main bronchus or lung hilum
- Tumors invading large blood vessels with risk of fatal bleeding
- Severe bone damage from metastases or multiple load-bearing bone metastases
- Recurrent serous cavity effusions requiring frequent drainage
- Recent use (within 2 weeks) of anti-tumor traditional Chinese medicines or prior use of certain anti-angiogenic drugs for NSCLC
- Previous docetaxel treatment for advanced NSCLC
- Unacceptable toxicity from prior anti-PD-(L)1 treatment
- Use of immunomodulatory drugs within 30 days before treatment
- Need for systemic corticosteroids or immunosuppressants within 14 days before randomization
- Incomplete recovery from prior treatment toxicities except specified exceptions
- Severe liver, kidney, cardiovascular, or gastrointestinal diseases
- History of immunodeficiency, active autoimmune diseases, organ transplantation
- Bleeding disorders or recent major surgery or trauma
- Poorly controlled diabetes
- Recent or active severe infections or fever
- Severe lung diseases or active tuberculosis
- Severe allergies or hypersensitivity to study drugs or components
- History of severe psychiatric disorders or substance abuse
- Recent participation in other clinical trials or vaccinations
- Pregnant or breastfeeding women
- Any condition that may increase risk or is judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Central People's Hospital of Huizhou
Huizhou, Guangdong, China, 516001
Not Yet Recruiting
2
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China, 473000
Actively Recruiting
3
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China, 222000
Actively Recruiting
4
Weihai Municipal Hospital
Weihai, Shandong, China, 264299
Not Yet Recruiting
5
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
K
Kai Li, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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