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Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)

NCT04772287 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2021-02-26

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Toripalimab

Toripalimab: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.

DRUG

Toripalimab mimetic (placebo)

Placebo: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2026-12-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772287 on ClinicalTrials.gov