A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Pemetrexed + Platinum Chemotherapy With or Without Toripalimab (JS001) in Advanced Non-small Cell Lung Cancer (NSCLC) Participants With TKI-resistant EGFR-mutated Tumors

Shanghai Junshi Bioscience Co., Ltd.2 sites in 1 country440 target enrollmentMay 6, 2019

ConditionsNon-small Cell Lung Cancer

InterventionsTORIPALIMAB INJECTION(JS001 )

DrugsTORIPALIMAB INJECTION(JS001 )

Overview

Phase: Phase 3
Intervention: TORIPALIMAB INJECTION(JS001 )
Conditions: Non-small Cell Lung Cancer
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 440
Locations: 2
Primary Endpoint: OS
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with chemotherapy in Advanced Non-small Cell Lung Cancer (NSCLC) Participants with TKI-resistant EGFR-mutated Tumors; and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population.

About 440 subjects with advanced non-small cell lung cancer with activated EGFR mutation will be 1:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors:

The history of the previous lines of EGFR-TKI treament ( 1st or 2nd generation of TKI vs. 3rd generation of TKI vs. 1st or 2nd generation of TKI + 3rd generation of TKI) ; Disease stage (IIIB-C vs. IV);

Registry

clinicaltrials.gov

Start Date

May 6, 2019

End Date

August 8, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only the patients meeting all the following criteria can be eligible to participate in the trial:
•Fully informed consent and signed ICF;
•Age of 18-75 years;
•Histologically and/or cytologically confirmed advanced or recurrent stage III B-C or IV (AJCC Version 8) NSCLC with TKI-resistant EGFR-mutated tumors, which also satisfy following conditions: Without T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.) treatment failure;If with T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.),participants are required to have osimertinib or other 3rd generation EGFR-TKI treatment failure prior to enrollment.Participants with osimertinib treatment failure as 1st line therapy (regardless of their EGFR T790M mutation status);Previous neoadjuvant/adjuvant chemotherapy is allowed, but the time interval between the last dose of chemotherapy and recurrence/metastasis must be at least 6 months.
•With at least one measurable disease per RECIST 1.1;
•Agree to provide formalin fixed tumor specimen after EGFR-TKI treatment failure or provide fresh biopsy tissue;
•ECOG performance status of 0-1;
•Life expectancy ≥ 3 months;
•Good organ function;
•Any adverse event resulting from prior treatment, surgery, or radiotherapy must return to grade 0 or 1 according to NCI-CTCAE v5.0, except for alopecia of any grade;

Exclusion Criteria

•Exclusion of tumor histology or cytology confirmed the presence of small cell lung cancer components, or squamous cell carcinoma components of more than 10%;
•Combined with other driver mutations with known therapeutic drug, including but not limited to: ALK rearrangement, ROS1 mutation, BRAF600E mutation;
•Previous systematic chemotherapy for advanced NSCLC;
•Subjects with no measurable lesions;
•Subjects with cancer meningitis and spinal cord compression;
•Subjects with untreated central nervous system (CNS) tumor metastasis;
•Subjects were previously treated with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 agent;
•Subjects with any active, known or suspected autoimmune disease;
•Subjects who are now participating in other clinical studies or the last dose of prior investigational drug was given in \< 4 weeks (or 5 half-lives) from the first investigational product administration of this study;
•Subjects who were expected to receive any other antitumor therapy (eg, other maintenance therapy for NSCLC, radiotherapy, and/or surgical excision);