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Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924050
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

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 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);


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: TORIPALIMAB INJECTION(JS001 ) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Pemetrexed

Arm Intervention/treatment
Experimental: Group TORIPALIMAB combined with standard chemotherapy Drug: TORIPALIMAB INJECTION(JS001 )
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

Placebo Comparator: Group Placebo combined with standard chemotherapy Drug: TORIPALIMAB INJECTION(JS001 )
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.




Primary Outcome Measures :
  1. PFS (Progression Free Survival) by investigator [ Time Frame: Approximately 2 years ]
    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)


Secondary Outcome Measures :
  1. PFS (Progression Free Survival) by IRC (Independent Review Board) [ Time Frame: Approximately 2 years ]
    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

  2. ORR (Objective Response Rate) [ Time Frame: Approximately 2 years ]
    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

  3. DOR (Duration of Response) [ Time Frame: Approximately 2 years ]
    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

  4. DCR (Disease of Response) [ Time Frame: Approximately 2 years ]
    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

  5. TTR (Time to Response) [ Time Frame: Approximately 2 years ]
    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

  6. OS (Overall Survival) OS OS [ Time Frame: Approximately 2 years ]
    Overall survival (OS);

  7. Incidence of AEs/SAEs [ Time Frame: Approximately 2 years ]
    Adverse events (AEs) study drug related; serious adverse events (SAEs)study drug related; abnormal value of Lab test according to NCI-CTCAE V5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924050


Contacts
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Contact: Caicun Zhou, prof +8621-65115006-3050 caicunzhoudr@163.com

Locations
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China
Shanghai Pulmonary Hospital Recruiting
Shanghai, China
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.

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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT03924050    
Other Study ID Numbers: JS001-CT25-III-NSCLC
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors