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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wen-Zhao Zhong, MD
• Email: 13609777314@163.com
• Phone: 86-13609777314

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC

  This study tests whether adding propranolol to toripalimab and platinum-based chemotherapy is safe and tolerable for people with resectable non-small cell lung cancer before surgery.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886229

• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

  This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan and 8 other locations · NCT07855965

• Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy

  This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.

  Recruiting at 2 sites Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 1 other locations · NCT07835035

• SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

  This phase 2 trial tests whether giving SABR radiation together with axitinib and toripalimab can shrink tumors and help patients with up to five metastatic sites from clear cell renal cell carcinoma.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07744932

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.