Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial

Shanghai Pulmonary Hospital, Shanghai, China0 sites341 target enrollmentMarch 31, 2021

ConditionsNon Small Cell Lung Cancer

InterventionsToripalimab Toripalimab mimetic (placebo)

DrugsToripalimab Toripalimab mimetic (placebo)

Overview

Phase: Phase 3
Intervention: Toripalimab
Conditions: Non Small Cell Lung Cancer
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Enrollment: 341
Primary Endpoint: Disease-free survival (DFS)
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a randomized, controlled, double-blind, single-center Phase III clinical study in patients with EGFR/ALK mutation negative stage II-IIIB (N2) non-small cell lung cancer (NSCLC) after complete tumor resection. To evaluate the effectiveness and safety of toripalimab compared with placebo combined with platinum-containing dual-drug chemotherapy.

Registry

clinicaltrials.gov

Start Date

March 31, 2021

End Date

December 30, 2027

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Responsible Party

Principal Investigator

Peng Zhang

Director of thoracic department

Shanghai Pulmonary Hospital, Shanghai, China

Eligibility Criteria

Inclusion Criteria

•Volunteer to participate in this clinical study, understand the research procedures and be able to sign written informed consent.
•Age ≥18 years old.
•Histological diagnosis of primary non-small cell lung cancer (NSCLC).
•An MRI or CT scan of the brain must be performed before lung cancer resection, and it is confirmed that there is no brain metastasis. For patients who have not been examined before surgery, if they have a brain MRI or CT scan before randomization and it is confirmed that there is no brain metastasis, they can still be enrolled.
•Total resection of primary lung cancer (R0) and systemic lymph node dissection must be performed: complete resection includes lobectomy, sleeve resection, and bilobectomy; systemic lymph node dissection includes hilar and mediastinal lymph node dissection Or sampling, including at least 6 groups of lymph nodes, of which 3 groups are from intrapulmonary (lobar, interlobar or segment) and hilar lymph nodes, and 3 groups are from mediastinal lymph nodes including subcarinal lymph nodes; all surgical margins must be tumor-negative; respectively; The removed mediastinal lymph nodes or the marginal lymph nodes of the removed lung lobes cannot have extranodal invasion.
•Postoperative pathologically confirmed NSCLC patients with stage II, IIIA and IIIB (N2), the disease is staged according to the American Joint Committee on Cancer (AJCC) 8th edition lung cancer staging standard.
•Confirmed as negative for EGFR/ALK mutation.
•Complete recovery from surgery during randomization, and complete postoperative wound healing must be achieved after any surgery;
•The Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0 or 1 and has not deteriorated 2 weeks before the first administration of the study drug, and the minimum expected survival is greater than 12 weeks.
•Other major organs (liver, kidney, blood system, etc.) function well:

Exclusion Criteria

•Unresectable or metastatic disease, pathology report showing positive surgical margins or extranodal invasion under the microscope, or leftover lesions during surgery.
•Patients with lung adenocarcinoma with clear EGFR mutation or ALK rearrangement.
•Upper sulcus lung cancer.
•Only patients undergoing segmental resection or wedge resection.
•Because NSCLC has previously received any anti-cancer treatment other than surgery, including preoperative and postoperative chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR and other pathways, monoclonal Antibodies, etc.), immunotherapy, research therapy, etc.; within 14 days before the first administration of the research drug, Chinese medicines and Chinese medicine preparations with anti-tumor therapy indications or tumor adjuvant therapy effects have been used;
•Suffered from other malignant tumors before the start of the trial, except for the following medical history:
•Malignant tumors that have been cured, have been inactive for more than 5 years and have a very low risk of recurrence before being selected for the study;
•Adequately treated non-melanoma skin cancer or malignant lentigines with no evidence of disease recurrence;
•Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
•Localized prostate cancer after radical surgery.

Arms & Interventions

Toripalimab

Intervention: Toripalimab

Placebo

Intervention: Toripalimab mimetic (placebo)

Outcomes

Primary Outcomes

Disease-free survival (DFS)

Time Frame: up to 40 months

It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).

Secondary Outcomes

Health related quality of life (HRQol)(up to 12 months)
5-year overall survival rate(From the completion of the intervention to 5 years.)
Overall survival (OS)(up to 60 months)
Safety: frequency of severe adverse events(up to 18 months)