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NCT Number: NCT07039656

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Wen-Zhao Zhong

PRINCIPAL_INVESTIGATOR

Wen-Zhao Zhong, MD

CONTACT

[email protected]

86-15920473691

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toripalimab

Drug

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

cisplatin-based chemotherapy

Drug

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 outcomes

  1. 2-year Disease-Free Survival

    Time frame: 24 months

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: 60 months

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

  2. Adverse events

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-Zhao Zhong, MD

CONTACT

[email protected]

86-13609777314

Sponsors and collaborators

Lead sponsor

Wen-zhao ZHONG

Other

Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jun 26, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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