Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy

Korábbi kezelés

• Treatment with prior systemic chemotherapy at any time
• Active hepatitis B and C patients will need to be on relevant antiviral therapy, have HBV-DNA \<2000 IU/ml (\<104 copies/ml) and have received anti-HBV therapy for at least 14 days prior to study participation, and continue therapy for the duration of the treatment period; HCV RNA-positive patients must be on antiviral therapy and have a liver function that is within the elevated CTCAE grade 1;
• Patients with previous allogeneic stem cell or parenchymal organ transplantation

Más betegség

• Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
• Patient has a history of active autoimmune disease or autoimmune disease that may recur
• History of allergy to monoclonal antibody drugs
• Having a mental illness or any other condition that renders treatment non-compliant
• The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.

Laborértékek

• Confirmed EGFR or ALK mutations
• Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;

Egyéb

• Patients unable or unwilling to sign the informed consent form

• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Adequate organ function performed within 10 days of treatment initiation
• Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, IUDs, etc., during the study period and for the last 6 months of study drug use. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilised (e.g. hysterectomy, bilateral adnexectomy or radiation ovarian irradiation).