Toripalimab Combined With Chemotherapy as Adjuvant Therap... | NCT07039656

Status Module

Name	Class
Shanghai Junshi Bioscience Co., Ltd.	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage IB-IIIB participants following completely resection without neoadjuvant therapy	Experimental		Drug: Toripalimab Drug: Cisplatin-based chemotherapy
Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy	Experimental		Drug: Toripalimab Drug: Cisplatin-based chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toripalimab	Drug	Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).	Stage IB-IIIB participants following completely resection without neoadjuvant therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	OS was defined as the time from the start of treatment to the date of death.	60 months
Adverse events	Incidence of AE/SAE which has been confirmed correlation with treatment.

Eligibility Module

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.