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Report for Clinical Trial NCT03924050

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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 chemotherapyin 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 350 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 line of TKI vs. 3rd line of TKI vs. 1st or 2nd line of TKI + 3rd line of TKI) ; Disease stage (IIIB-C vs. IV);

NCT03924050 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: TORIPALIMAB INJECTION(JS001 )

Description: TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Type: Drug
Group Labels: 2

Group Placebo combined with standard chemotherapy Group TORIPALIMAB combined with standard chemotherapy


Primary Outcomes

Description: Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

Measure: PFS (Progression Free Survival) by investigator

Time: Approximately 2 years

Secondary Outcomes

Description: PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

Measure: PFS (Progression Free Survival) by IRC (Independent Review Board)

Time: Approximately 2 years

Description: Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

Measure: ORR (Objective Response Rate)

Time: Approximately 2 years

Description: Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

Measure: DOR (Duration of Response)

Time: Approximately 2 years

Description: Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

Measure: DCR (Disease of Response)

Time: Approximately 2 years

Description: Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

Measure: TTR (Time to Response)

Time: Approximately 2 years

Description: Overall survival (OS);

Measure: OS (Overall Survival) OS OS

Time: Approximately 2 years

Description: Adverse events (AEs) study drug related; serious adverse events (SAEs)study drug related; abnormal value of Lab test according to NCI-CTCAE V5.0

Measure: Incidence of AEs/SAEs

Time: Approximately 2 years

Purpose: Treatment

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 T790M

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.) --- T790M ---

treatment failure;If with T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.),participants --- T790M ---

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. --- T790M ---

- 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: - 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, and KRAS 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 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.) --- T790M ---



HPO Nodes


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