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NCT07039656RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
211 (estimated)
First submitted
18 Jun 2025
Start date
1 Jan 2025
Primary completion date
30 Dec 2028
Lead sponsor
Wen-zhao ZHONG
Diseases
Lung cancer
NCT number
NCT07039656

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 211
  • From 1 Jan 2025 to the primary completion date, 30 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Lab values

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

Other

  • Patients unable or unwilling to sign the informed consent form

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangdong Provincial People's Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.