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Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC. (NAJSCR)

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ClinicalTrials.gov Identifier: NCT03623776
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in treating patients with resectable NSCLC.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Drug: JS001 Drug: Pemetrexed Drug: Carboplatin Procedure: Thoracic Surgery Phase 2

Detailed Description:
Surgery in combination with preoperative or postoperative chemotherapy is the recommended therapeutic approach for patients with resectable non-small cell lung cancer (NSCLC). However, the prognosis of early-stage NSCLC remains to be improved, with 5-year survival rates ranging from 50% for stage IA to 20% for stage IIIA. Antibodies that block the PD-1 protein have provided a major treatment advance in patients with cancer. JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which has shown its efficacy in the treatment of a variety of malignancies. This study is to studying neoadjuvant JS001, or JS001 in combination with chemotherapy to see how well it works in treating patients with resectable NSCLC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Neoadjuvant JS001, or JS001 in Combination With Chemotherapy in Resectable NSCLC.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JS001 alone
Subjects receive JS001 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
Drug: JS001
JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
Other Name: Toripalimab

Procedure: Thoracic Surgery
Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Experimental: JS001+chemotherapy
Subjects receive JS001 240 mg, pemetrexed of 500 mg/m^2 and carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Drug: JS001
JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
Other Name: Toripalimab

Drug: Pemetrexed
Subjects receive pemetrexed of 500 mg/m^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Other Name: Pemetrexed Disodium

Drug: Carboplatin
Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
Other Name: CBP

Procedure: Thoracic Surgery
Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.




Primary Outcome Measures :
  1. 3-year Disease Free Survival [ Time Frame: 3 years after the last patient is registered ]
    Disease-free survival was assessed from registration to disease recurrence or death as a result of any cause.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events (AEs) [ Time Frame: 2 years after the last patient is registered ]
    Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

  2. Number of participants with perioperative complications [ Time Frame: 2 years ]
    Perioperative complications will be recorded

  3. 3-year Overall survival [ Time Frame: 3 years after the last patient is registered ]
    Overall survival was assessed from registration to death as a result of any cause.

  4. Pathologic Response [ Time Frame: 3 months ]
    To assess pathologic response to neoadjuvant JS001, or JS001 in combination with chemotherapy in resected tumor and lymph nodes. Major pathologic response was defined as <10% residual viable tumor cells in the resection specimen.



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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:

  • Target population is high risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at SYSUCC. This may include clinical stage IB (≥4cm), II and IIIA. Subjects with N3 nodal involvement are not included.
  • Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
  • Written informed consent provided.
  • Male and female patients aged ≥18 years, < 75 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • Blood and specimens before and after treatment must be provided
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥12 weeks.
  • Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  • Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

  • Known severe hypersensitivity to JS001 or any of the excipients of this product.
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Prior chemotherapy or radiotherapy.
  • Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Known history of active Hepatitis B or C.
  • Women who are pregnant or nursing.
  • Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

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): NCT03623776


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Si-Yu Wang Sun Yat-sen University

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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03623776     History of Changes
Other Study ID Numbers: GASTO1038
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Si-Yu Wang, Sun Yat-sen University:
Non-Small Cell Lung Cancer
Neoadjuvant
Programmed Death-1

Additional relevant MeSH terms:
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Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors