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

NCT03623776 | Withdrawn Phase 2 DMC

• 1 other identifier: GASTO1038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Keywords

Non-Small Cell Lung Cancer; Neoadjuvant; Programmed Death-1

Outcome Measures

Primary Outcomes (1)

• 3-year Disease Free Survival

  Disease-free survival was assessed from registration to disease recurrence or death as a result of any cause.

  3 years after the last patient is registered

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events (AEs)

  2 years after the last patient is registered

• Number of participants with perioperative complications

  2 years

• 3-year Overall survival

  3 years after the last patient is registered

• Pathologic Response

  3 months

Study Arms (2)

JS001 alone

EXPERIMENTAL

Subjects receive JS001 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.

Drug: JS001; Procedure: Thoracic Surgery

JS001+chemotherapy

EXPERIMENTAL

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; Drug: Pemetrexed; Drug: Carboplatin; Procedure: Thoracic Surgery

Interventions

JS001 DRUG

JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.

Also known as: Toripalimab

JS001 alone; JS001+chemotherapy

Pemetrexed DRUG

Subjects receive pemetrexed of 500 mg/m\^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.

Also known as: Pemetrexed Disodium

JS001+chemotherapy

Carboplatin DRUG

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

Also known as: CBP

JS001+chemotherapy

Thoracic Surgery PROCEDURE

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

JS001 alone; JS001+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab; Pemetrexed; Carboplatin; Thoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Surgical Procedures, Operative

Study Officials

• Si-Yu Wang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 9, 2018
• Study Start: February 1, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)