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

Phase 2

Recruiting

• Conditions: Stage IB-IIIB NSCLC; Stage IIB-III NSCLC
• Interventions: Drug: Toripalimab; Drug: Cisplatin-based chemotherapy

• Registration Number: NCT07039656
• Lead Sponsor: Wen-zhao ZHONG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Submitted: 2025-08-03
• Last Update Posted: 2025-08-07
• Primary Completion: 2028-12-30
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 211

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage IB-IIIB participants following completely resection without neoadjuvant therapy	Toripalimab	-
Stage IB-IIIB participants following completely resection without neoadjuvant therapy	Cisplatin-based chemotherapy	-
Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy	Toripalimab	-
Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy	Cisplatin-based chemotherapy	-

Primary Outcome Measures

Name	Time	Method
2-year Disease-Free Survival	24 months	DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	60 months	OS was defined as the time from the start of treatment to the date of death.
Adverse events	24 months	Incidence of AE/SAE which has been confirmed correlation with treatment.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China