Actively Recruiting
Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB
Led by Hunan Province Tumor Hospital · Updated on 2024-09-19
120
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-based chemotherapy with resectable stage II-IIIB non-small cell lung cancer.
CONDITIONS
Official Title
Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 to 75 years, any gender
- Previously untreated, histologically confirmed resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer
- Resectable status confirmed by PET-CT or biopsy and thoracic surgeon assessment
- Squamous cell carcinoma patients do not require genetic testing; adenocarcinoma patients must have EGFR, ALK, and ROS1 testing
- Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1
- Submission of 20 tissue sections for biomarker evaluation from fresh or recent archival tumor samples
- ECOG performance status score of 0 or 1
- Good organ function including hematology, kidney, liver, endocrine, coagulation, and cardiac function as specified
- Lung function sufficient to tolerate pneumonectomy surgery
- Women must agree to contraception during and for 6 months after the study; negative pregnancy test within 7 days before study start; men must also agree to contraception during and 6 months post-study
You will not qualify if you...
- Neuroendocrine carcinoma or sarcomatoid tumor diagnosis
- Locally advanced unresectable or metastatic disease as defined by specific lymph node involvement and invasion criteria
- Known EGFR mutations or ALK, ROS1 translocations in non-squamous cell carcinoma
- Prior systemic anticancer therapy for early stage NSCLC
- History or current interstitial lung disease or pneumonia requiring steroid treatment
- Active tuberculosis or infections needing systemic treatment
- Autoimmune diseases or immunodeficiency except stable hypothyroidism or controlled type I diabetes
- Active hepatitis B or C infections
- Known HIV infection
- Live vaccines within 30 days before first dose
- Grade 2 or higher peripheral neuropathy
- Prior treatment with PD-1/PD-L1 or T cell receptor targeting drugs
- Severe uncontrolled diseases including cardiac, infections, liver disease, diabetes, or psychiatric disorders
- Use of immunosuppressive drugs beyond defined limits before study
- Pregnant or breastfeeding women
- Prisoners or involuntarily detained individuals
- Bleeding disorders or use of certain anticoagulants
- Allergy to study drug components
- Any other conditions that may endanger safety or study completion as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
Yongchang C Zhang, MD
CONTACT
N
Nong C Yang, 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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