Toripalimab plus chemotherapy as additional treatment after surgery for non-small cell lung cancer

Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial

This tests whether adding toripalimab to cisplatin-based chemotherapy after complete surgical removal helps people with resected Stage IB–IIIB non-small cell lung cancer stay cancer-free longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 211 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Drugs / interventions: chemotherapy, radiation, toripalimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07039656 on ClinicalTrials.gov

What this trial studies

This two-cohort, multicenter Phase II study gives 3–4 cycles of toripalimab (JS001) combined with cisplatin-based chemotherapy followed by up to one year of toripalimab maintenance in adults with completely resected NSCLC. Participants are stratified into Cohort 1 (Stage IB–IIIB without prior neoadjuvant therapy) and Cohort 2 (Stage IIB–III with non‑MPR or MPR plus residual lymph node positivity after neoadjuvant chemoimmunotherapy). The main outcomes are disease-free survival and overall survival, with safety and tolerability monitored throughout treatment. Eligible patients are aged 18–75 with ECOG 0–1, adequate organ function, and surgery completed within the protocol-specified window.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with completely resected Stage IB–IIIB NSCLC who meet the cohort-specific neoadjuvant criteria, have ECOG 0–1, and adequate organ function.

Not a fit: Patients with poor performance status, incomplete resection, significant organ dysfunction, or disease outside the specified stage or timing windows are unlikely to benefit.

Why it matters

Potential benefit: If successful, the regimen could lower recurrence risk and extend disease-free and overall survival after surgery.

How similar studies have performed: Other adjuvant trials of PD-1/PD-L1 drugs (for example, IMpower010 with atezolizumab) have shown benefit in resected NSCLC, so this approach has supporting precedent though toripalimab-specific data are more limited.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Wen-Zhao Zhong, MD

Conditions: Stage IB-IIIB NSCLC, Stage IIB-III NSCLC, Toripalimab, MRD, Adjuvant therapy