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RecruitingNCT07039656Updated Aug 7, 2025

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

A Phase 2 interventional study of Toripalimab and Cisplatin-based chemotherapy in Stage IB-IIIB NSCLC and Stage IIB-III NSCLC, sponsored by Wen-zhao ZHONG. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Wen-zhao ZHONG · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2025, registered Jun 2025).
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
211
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Stage IB-IIIB NSCLC
  • Stage IIB-III NSCLC

Keywords

  • Toripalimab
  • MRD
  • Adjuvant therapy
03

In context

Lead sponsor

Wen-zhao ZHONG is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
211 participants (estimated)

Study arms

  • Experimental
    Stage IB-IIIB participants following completely resection without neoadjuvant therapy

    Drug: Toripalimab · Drug: Cisplatin-based chemotherapy

  • Experimental
    Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy

    Drug: Toripalimab · Drug: Cisplatin-based chemotherapy

Interventions

  • DrugToripalimab

    Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).

  • DrugCisplatin-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

06

What researchers measure

Primary outcomes

  1. 2-year Disease-Free Survival

    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.

    Time frame: 24 months

Secondary outcomes

  1. Overall Survival

    OS was defined as the time from the start of treatment to the date of death.

    Time frame: 60 months

  2. Adverse events

    Incidence of AE/SAE which has been confirmed correlation with treatment.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510080, China
    • Wen-Zhao Zhong, MD · Contact · 13609777314@163.com · 86-15920473691
    • Wen-Zhao Zhong · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Treatment and survival data for participants will be presented in the corresponding manuscript.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07039656
Lead sponsor
Wen-zhao ZHONG
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
Responsible party
Wen-zhao ZHONG (Head of Thoracic Surgery, Guangdong Provincial People's Hospital) — Sponsor-investigator
First posted
Jun 26, 2025
Start date
Jan 1, 2025
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Aug 7, 2025

Study contacts

Wen-Zhao Zhong, MD
Contact
13609777314@163.com
86-13609777314

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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