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Recruiting NCT07039656

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

Phase II Interventional Stage IB-IIIB NSCLC Stage IIB-III NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toripalimab, Cisplatin-based chemotherapy.
Who it may be relevant to
Registry conditions: Stage IB-IIIB NSCLC, Stage IIB-III NSCLC. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Toripalimab
    Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).
  • Drug Cisplatin-based chemotherapy
    Cisplatin\[75 mg/m\^2 IV Q3W\]/carboplatin\[AUC 5 IV Q3W\]+paclitaxel\[260 mg/m\^2 IV Q3W\] or cisplatin\[75 mg/m\^2 IV Q3W)\]/carboplatin\[AUC 5 IV Q3W\]+ pemetrexed\[500 mg/m2 IV Q3W\],dependent on tumor histology. Participants will receive Chemotherapy for 3-4 cycles

Primary outcome measures

  • 2-year Disease-Free Survival [Time frame: 24 months]
Secondary outcome measures (2)
  • Overall Survival [Time frame: 60 months]
  • Adverse events [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
  • Treatment with prior systemic chemotherapy at any time
  • Confirmed EGFR or ALK mutations
  • Patient has a history of active autoimmune disease or autoimmune disease that may recur
  • 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;
  • Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;
  • History of allergy to monoclonal antibody drugs
  • Patients with previous allogeneic stem cell or parenchymal organ transplantation
  • Having a mental illness or any other condition that renders treatment non-compliant
  • Patients unable or unwilling to sign the informed consent form
  • The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07039656 · KY2024-1057-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗