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

NCT ID: NCT07039656

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2030-12-31

Brief 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.

Conditions

Stage IB-IIIB NSCLC; Stage IIB-III NSCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage IB-IIIB participants following completely resection without neoadjuvant therapy

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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

Cisplatin-based chemotherapy

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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

Cisplatin-based chemotherapy

Intervention Type: 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

Interventions

Toripalimab

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: collaborator

Wen-zhao ZHONG

OTHER

Sponsor Role: lead

Responsible Party

Wen-zhao ZHONG

Head of Thoracic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen-Zhao Zhong, MD

Role: CONTACT

13609777314@163.com

86-13609777314

Facility Contacts

Wen-Zhao Zhong, MD

Role: primary

13609777314@163.com

86-15920473691

Other Identifiers

KY2024-1057-03

Identifier Type: -

Identifier Source: org_study_id