Status:
UNKNOWN
Neoadjuvant Chemotherapy and Tilelizumab in Stage III（cTNM-IIIA.IIIB）Non-small-cell Lung Cancer
Lead Sponsor:
West China Hospital
Conditions:
Stage III
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a prospective, one-arm, phase II study aimed at evaluating tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment, supplemented with tislelizumab afte...
Detailed Description
The study included a screening period, a treatment period (including neoadjuvant treatment, surgery and postoperative adjuvant treatment), and a survival follow-up period. Patients who meet the admis...
Eligibility Criteria
Inclusion
- Untreated and histologically confirmed stage III (T2N2, T3-4N1-2) NSCLC (as defined by the American Joint Committee on Cancer 8th Edition)
- If the driver gene negative for EGFR sensitive mutations and ALK and ROS1 gene fusion mutations has not been detected before, test specimen tissue/blood
- Tumor assessment scan using (CT) and (PET-CT) or magnetic resonance (MRI)
- The date of signing the informed consent is ≥18 years old and ≤65 years old
- Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1
- Have measurable diseases assessed by the investigator according to RECIST Version 1.1
- After neoadjuvant treatment, the MDT team and the chief surgeon comprehensively assessed and confirmed that they meet the requirements for radical resection
- After neoadjuvant therapy, evaluate once every 2 cycles. For PD, discontinue tislelizumab and receive simultaneous radiotherapy. PR/SD patients will discuss MDT and adopt surgical treatment;
- Good cardiopulmonary function, able to tolerate surgery
- Eligible to receive platinum-containing dual-drug chemotherapy
- Can provide representative pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis.
Exclusion
- Have received any treatment for the current lung cancer, including chemotherapy or radiotherapy 1.Patients with positive driver genes are known to carry EGFR mutations or ALK, ROS1 gene translocations
- After neoadjuvant treatment, pneumonectomy is still required at the last evaluation
- Suffered from any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent drugs\> 10 mg) or other immunosuppressive drugs in the 14 days before enrollment
- Adrenaline replacement steroids (daily doses\> 10 mg of prednisone or equivalent) are allowed for topical, ocular, intra-articular, intranasal or inhaled corticosteroids, and minimum systemic absorption is required, and they are prescribed Corticosteroids are short-term (≤7 days) medication, or used to treat non-autoimmune diseases
- A history of active autoimmune disease or autoimmune disease that may recur.
- Allow entry for patients with: well-controlled type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or predicted without external causes A disease that does not recur. The chest CT scan performed during the screening period has evidence of idiopathic pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), or a history of non-infectious pneumonia
- Severe infections occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia
- Severe chronic or active infections (including tuberculosis infection, etc.) that require systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment
- A history of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.
- Untreated patients with chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \<500 IU/mL), and cured hepatitis C patients can be included in the group.
- If any major surgery requiring general anesthesia has been performed ≤28 days before randomization.
- Previous allogeneic stem cell transplantation or organ transplantation. -
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04865705
Start Date
November 10 2020
End Date
June 10 2022
Last Update
April 29 2021
Active Locations (1)
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1
University
Chengdu, Sichuan, China, 610041