Actively Recruiting
WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-09
31
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.
CONDITIONS
Official Title
WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced NSCLC
- Disease progression after first-line treatment with a PD-1 inhibitor
- Expected survival time greater than 3 months
- Measurable target lesions on imaging with longest diameter greater than 1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate bone marrow reserve: ANC >1.5×10⁹/L; ALC ≥0.3×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobin ≥100 g/L
- Adequate organ function: AST ≤2.5 times ULN (≤5 ULN if tumor infiltration); ALT ≤2.5 times ULN (≤5 ULN if tumor infiltration); Total bilirubin ≤1.5 times ULN (≤3 ULN if tumor infiltration); Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/min; Lung reserve with ≤Grade 1 dyspnea and oxygen saturation >91% without supplemental oxygen; INR ≤1.5 times ULN; APTT ≤1.5 times ULN
- Women of childbearing potential must have a negative urine pregnancy test
- Male and female patients capable of having children must agree to use effective contraception during the study and for 1 year after last treatment
You will not qualify if you...
- Symptomatic central nervous system (CNS) metastases; asymptomatic or treated stable CNS metastases allowed
- History of CNS disorders including epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, psychiatric disorders, or CNS autoimmune diseases
- Immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening if deemed unsuitable for enrollment
- Discontinued systemic corticosteroids less than 72 hours before cell infusion, except physiological replacement doses
- Prior adoptive cell therapy
- History of organ/tissue transplantation
- Active systemic autoimmune diseases under treatment
- Positive tests for hepatitis B, hepatitis C, syphilis, HIV, or elevated viral DNA levels
- Major surgery within 4 weeks prior to screening if unsuitable for enrollment
- Other malignancies within past 2 years except treated non-melanoma skin cancer or in situ carcinoma
- Cardiac conditions: LVEF ≤50%, NYHA class III/IV heart failure, uncontrolled hypertension or pulmonary hypertension, recent myocardial infarction or cardiac surgery, significant valvular heart disease
- Tumor involvement of heart atrium or ventricle
- History of pulmonary interstitial fibrosis or severe COPD
- Urgent clinical emergencies due to tumor obstruction or compression
- Active bleeding
- History of deep vein thrombosis or pulmonary embolism within 6 months
- Vaccination with live vaccines within 6 weeks
- Active infection requiring treatment
- Participation in another interventional clinical study within 4 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
L
Liang Liu, MD. Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here