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

Wen-zhao ZHONG

Status and phase

Enrolling

Phase 2

Conditions

Stage IIB-III NSCLC

Stage IB-IIIB NSCLC

Treatments

Drug: Cisplatin-based chemotherapy

Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT07039656

KY2024-1057-03

Details and patient eligibility

About

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:

Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.

Enrollment

211 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.