Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI
NCT ID: NCT03924050
Last Updated: 2022-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
440 participants
INTERVENTIONAL
2019-05-06
2024-08-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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);
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group TORIPALIMAB combined with standard chemotherapy
TORIPALIMAB INJECTION(JS001 )
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Group Placebo combined with standard chemotherapy
TORIPALIMAB INJECTION(JS001 )
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TORIPALIMAB INJECTION(JS001 )
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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;
* Willing and able to follow protocol visits, treatment plans, laboratory tests and other study procedures;
* Women of childbearing potential must have negative serum pregnancy test within 3 days prior to the first dose of investigational product:
Exclusion Criteria
* 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);
* Subjects who received major surgery within 4 weeks prior to enrollment or were not fully recovered from prior surgery;
* Subjects with other malignancies requiring concurrent treatment;
* Subjects with grade II or above myocardial ischemia or myocardial infarction, or subjects with arrhythmia with poor control;
* Subjects with uncontrolled pleural/pericardial effusion, or with ascites requiring repeated drainage;
* Subjects with uncontrolled tumor-related pain;
* Subjects with severe allergic reactions to other monoclonal antibodies and subjects with severe allergic reactions to pemetrexed, platinum or its prophylaxis;
* Subjects with psychological disorder, alcohol alcoholism, drug abuse or drug dependency
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Peking University Shenzhen Hospital
Shenzhen, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Banyu Zhang
Role: primary
Zhu Li
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Jiang T, Wang P, Zhang J, Zhao Y, Zhou J, Fan Y, Shu Y, Liu X, Zhang H, He J, Gao G, Mu X, Bao Z, Xu Y, Guo R, Wang H, Deng L, Ma N, Zhang Y, Feng H, Yao S, Wu J, Chen L, Zhou C, Ren S. Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC: a multicenter phase-II trial. Signal Transduct Target Ther. 2021 Oct 15;6(1):355. doi: 10.1038/s41392-021-00751-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JS001-CT25-III-NSCLC
Identifier Type: -
Identifier Source: org_study_id