Actively Recruiting
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
Led by Wen-zhao ZHONG · Updated on 2025-08-07
211
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
Sponsors
W
Wen-zhao ZHONG
Lead Sponsor
S
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS). Researchers will compare outcomes between two cohorts: 1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy; 2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
CONDITIONS
Official Title
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form
- Age between 18 and 75 years, any gender
- Cohort 1: Histological diagnosis of Stage IB-IIIB NSCLC without prior anti-cancer treatment
- Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-major pathologic response or lymph node positivity after neoadjuvant chemoimmunotherapy (per AJCC 8th edition)
- Complete surgical resection of NSCLC within 60 days prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function confirmed within 10 days before starting treatment
- Agreement to use effective contraception during the study and for 6 months after last study drug use (for patients of childbearing potential)
You will not qualify if you...
- Diagnosis of small cell lung cancer
- Prior systemic chemotherapy treatment at any time
- Presence of EGFR or ALK mutations
- History of active autoimmune disease or autoimmune disease that may recur
- Active hepatitis B or C infection without appropriate antiviral therapy or uncontrolled liver function
- Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel, or pemetrexed
- History of allergy to monoclonal antibody drugs
- Previous allogeneic stem cell or organ transplantation
- Mental illness or other conditions preventing treatment compliance
- Unable or unwilling to provide informed consent
- Investigator's judgment that participation is unsuitable due to patient's condition
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wen-Zhao Zhong, 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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