About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03924050

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted August 6, 2020

Study Description

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:Non-small Cell Lung Cancer
  • Intervention/Treatment: Drug: TORIPALIMAB INJECTION(JS001 )
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/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.
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.
Outcome Measures
  • 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. ORR (Objective Response Rate) [ Time Frame: Approximately 2 years ]
    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;
  • 2. 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;
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

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

Locations

China
Shanghai Pulmonary Hospital
Shanghai

China
Peking University Shenzhen Hospital
Shenzhen

Sponsors and Collaborators

Shanghai Junshi Bioscience Co., Ltd.

More Information
  • Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03924050 History of Changes
  • Other Study ID Numbers: JS001-CT25-III-NSCLC
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: August 6, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Neoplasms Carcinoma, Non-Small-Cell Lung