Actively Recruiting
A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer
Led by Jiangsu Cancer Institute & Hospital · Updated on 2026-02-11
33
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, multicenter, open-label, single-arm Phase II clinical trial. The study recruits patients with stage III unresectable non-small cell lung cancer according to the 8th edition of the AJCC/UICC staging system. It aims to observe and evaluate the efficacy and safety of anti-PD-1/CTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.
CONDITIONS
Official Title
A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Histologically or cytologically confirmed squamous or non-squamous (EGFR/ALK/ROS1 negative) non-small cell lung cancer
- No prior local treatment (surgery or radiotherapy) or systemic anti-tumor treatment for the tumor
- Unresectable stage III disease according to the 8th edition AJCC TNM staging
- At least one measurable lesion by RECIST v1.1 on chest enhanced CT or PET/CT
- ECOG performance status of 0 or 1
- Able to tolerate induction therapy and surgery with recommended radical surgical resection and lymph node dissection
- Expected survival of at least 12 months
- Adequate major organ and marrow function including hematologic, liver, kidney, coagulation, and endocrine function
- Adequate cardiopulmonary function including pulmonary function and ECG QTc interval
- Women of childbearing potential must use reliable contraception or have negative pregnancy test prior to enrollment; men must agree to use contraception
- Voluntary informed consent and willingness to comply with study and follow-up requirements
You will not qualify if you...
- Contraindications to immunotherapy such as long-term corticosteroid use or history of radiation pneumonitis
- Severe allergy history to paclitaxel, docetaxel, platinum agents, or related medications
- Unstable systemic diseases including active infection, uncontrolled hypertension, unstable angina, liver or kidney disease, or metabolic disease
- Receipt of live vaccine within 28 days before treatment
- Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Active autoimmune diseases requiring treatment
- Active hepatitis B or C, HIV infection, or active tuberculosis
- Active infection requiring antimicrobial treatment
- History of allogeneic organ or hematopoietic stem cell transplantation
- Interstitial lung disease or history of interstitial pneumonia
- History of drug abuse or uncontrolled mental disorders
- Previous or concurrent untreated malignancies except certain cured cancers
- Pregnant or breastfeeding women or unwilling/unable to use effective contraception
- Other conditions judged by the investigator to affect study conduct or results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Provincial Cancer Hospital
Nanjing, China
Actively Recruiting
Research Team
M
Meiqi Shi, Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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