Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWen-zhao ZHONG
About this trial
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.
Eligibility criteria
Qualifiers
Signed Informed Consent Form
Patient with age ≥ 18 and ≤75 years old, gender is not limited.
Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)
Participants must have had complete resection of NSCLC 60 days
Disqualifiers
Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
Treatment with prior systemic chemotherapy at any time
Confirmed EGFR or ALK mutations
Patient has a history of active autoimmune disease or autoimmune disease that may recur
Trial design
Treatments tested in this trial
- Toripalimab
- Cisplatin-based chemotherapy
Treatment groups
211 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wen-zhao ZHONG
Lead sponsor
Guangdong Provincial People's Hospital
Sponsor institution
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
Source ClinicalTrials.gov