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

Launched by WEN-ZHAO ZHONG · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have had surgery to remove early to mid-stage non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. The trial is testing whether adding a medicine called toripalimab, together with chemotherapy, can help prevent the cancer from coming back and improve survival. After completing 3 to 4 cycles of this combined treatment, patients will continue to receive toripalimab alone for up to one year as a follow-up treatment.

To join this study, participants need to be between 18 and 75 years old, have had their lung cancer completely removed by surgery recently, and be generally healthy enough to start treatment. People with certain types of lung cancer, previous chemotherapy, or some health conditions like active autoimmune diseases or allergies to the study drugs cannot participate. If eligible, participants will receive the combination treatment and be closely monitored to see how well it works and to check for any side effects. This trial is currently looking for volunteers and aims to find better ways to help patients stay cancer-free after surgery.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed Consent Form
• • 2. Patient with age ≥ 18 and ≤75 years old, gender is not limited.
• • 3. 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)
• • 4. Participants must have had complete resection of NSCLC 60 days
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• • 6. Adequate organ function performed within 10 days of treatment initiation
• • 7. 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).
• Exclusion Criteria:
• • 1. Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
• • 2. Treatment with prior systemic chemotherapy at any time
• • 3. Confirmed EGFR or ALK mutations
• • 4. Patient has a history of active autoimmune disease or autoimmune disease that may recur
• • 5. 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;
• • 6. Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;
• • 7. History of allergy to monoclonal antibody drugs
• • 8. Patients with previous allogeneic stem cell or parenchymal organ transplantation
• • 9. Having a mental illness or any other condition that renders treatment non-compliant
• • 10. Patients unable or unwilling to sign the informed consent form
• • 11. The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.