Trial Title:
JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）
NCT ID:
NCT06505837
Condition:
Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
No Masking
Intervention:
Intervention type:
Drug
Intervention name:
Arm1: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy
Description:
The combination therapy of JS001sc and pemetrexed/platinum lasted for 4 cycles, after
which subjects who did not progress continued to receive JS001sc and pemetrexed
maintenance therapy, and the cumulative treatment of JS001sc did not exceed 35 cycles
(Each cycle is 21 days).
Arm group label:
Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy
Intervention type:
Drug
Intervention name:
Arm 2: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
Description:
The combination therapy of JS001 and pemetrexed/platinum lasted for 4 cycles, after which
subjects who did not progress continued to receive JS001 and pemetrexed maintenance
therapy, and the cumulative treatment of JS001 did not exceed 35 cycles (Each cycle is 21
days).
Arm group label:
Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
Summary:
This is a multicenter, open-Lable, randomized, phase III clinical study to compare the
pharmacokinetic profile, efficacy, and safety of Toripalimab injection (subcutaneous)
(JS001sc) and Toripalimab injection (JS001) in combination with standard chemotherapy as
first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer
Detailed description:
A randomized, open-label,multicenter, phase III clinical study was designed to enroll 356
participants with recurrent or metastatic Non-Squamous Non small cell lung cancer without
EGFR sensitive mutations or ALK fusion. They will be randomly assigned in a 1:1 ratio to
one of two treatment groups:Group A: JS001sc+ platinum-based chemotherapy；JS001sc, 360
mg, was administered subcutaneously (SC) once every 3 weeks (Q3W)；Chemotherapy:
pemetrexed + carboplatin/cisplatin, Q3W, up to 4 cycles, non-progressive subjects
pemetrexed monotherapy maintenance therapy. Group B: JS001+ platinum-based
chemotherapy；JS001, 240 mg, IV, Q3W；Chemotherapy: pemetrexed + carboplatin/cisplatin,
Q3W, up to 4 cycles, non-progressive subjects pemetrexed monotherapy maintenance therapy.
Both groups were treated until treatment termination criteria were met.
Criteria for eligibility:
Criteria:
Inclusion criteria：
1. Age ≥18 years at the time of signing informed consent, both male and female.
2. Histologically or cytologically confirmed relapsed or metastatic non-squamous NSCLC.
3. Proof of no detection of EGFR-sensitive mutations and ALK fusions.
4. No prior systemic anti-tumor therapy for advanced or metastatic non-squamous NSCLC.
Subjects who have received adjuvant therapy or neoadjuvant therapy (chemotherapy,
radiotherapy, or other treatments) for recurrent non-squamous NSCLC can be enrolled
if the interval between the last treatment and recurrence is more than 6 months.
5. Subject has at least 1 measurable lesion according to RECIST v1.1 criteria.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
7. Expected survival ≥ 12 weeks.
8. The function of vital organs meets the following requirements (Note: no blood
components and hematopoietic growth factors are allowed to be used within 14 days
before screening);
1. Absolute neutrophil count (ANC) ≥1.5×109/L
2. Platelet ≥ 100×109/L;
3. Hemoglobin ≥9 g/dL;
4. Bilirubin ≤1.5× upper limit of normal (ULN);
5. Alanine aminotransferase (ALT) ≤ 2.5× ULN, aspartate aminotransferase (AST) ≤
2.5× ULN;
6. Creatinine clearance (CrCL) ≥ 60 mL/min (cisplatin) or CrCL ≥50 mL/min
(carboplatin) (Cockcroft-Gault formula);
7. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, International
normalized ratio (INR) ≤ 1.5 (for prophylactic anticoagulation at stable doses,
drug-specific monitoring requirements are acceptable beyond this range).
9. Female subjects of childbearing potential, as well as male subjects whose partner is
a female of childbearing potential, are required to use a highly effective
contraceptive method for the duration of study treatment and for at least 6 months
after the last treatment.
10. Voluntarily join this study, sign the informed consent form, have good compliance,
and cooperate with follow-up plan.
Exclusion criteria：
1. Concomitant study disease states of:
1. Histological or cytological pathology of the tumor confirmed with small cell
lung cancer component or sarcomatoid lesion, or squamous cell carcinoma
component >10%;
2. Patients with known meningeal metastases;
3. Patients with untreated brain metastases, who have received radiation therapy
for brain metastases and are judged by the investigator to be stable brain
metastases can be enrolled, and the criteria for stability need to meet all of
the following conditions: no symptoms related to brain metastases,
corticosteroid therapy needs to be discontinued at least 7 days before study
drug administration, and no disease progression is found after the end of
treatment for brain metastases and before randomization imaging compared with
pre-treatment imaging (at least 4 weeks apart);
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
repeated drainage (once a month or more frequently);
5. Spinal cord compression that has not undergone radical treatment with surgery
and/or radiotherapy, or previously diagnosed spinal cord compression that has
no clinical evidence of stable disease for ≥ 4 weeks prior to enrollment after
treatment;
2. Have received any of the following treatments:
1. Received local small-area radiotherapy (such as palliative radiotherapy for
bone metastases) within 14 days prior to the first study drug administration;
2. Prior immune-mediated therapy, including but not limited to anti-PD-1,
anti-PD-L1, or anti-CTLA-4 therapy (or any other antibodies acting on T cell
synergistic stimulation or checkpoint pathways such as IDO, IL-2R, GITR);
3. Receipt of any investigational drug within 4 weeks or 5 half-lives prior to the
first dose of study drug, whichever is shorter;
4. Concurrent enrollment in another clinical study, unless it is an observational
(non-interventional) clinical study, or the subject is in the follow-up period
of the interventional clinical study;
5. Systemic therapy with corticosteroids (> 10 mg prednisone equivalent dose per
day) or other immunosuppressants within 2 weeks prior to the first dose of
study drug. Inhaled or topical corticosteroids are permitted. Receipt of
short-term corticosteroids (such as pre-intravenous contrast) within 2 weeks
prior to the first dose of study drug is permitted;
6. Subjects who have received proprietary Chinese medicines or immunomodulatory
drugs with anti-tumor indications (thymus peptide, interferon, interleukin,
etc.) within 2 weeks before the first dose of study drug, or who need to
continue to receive these drugs during the study;
7. Those who have been vaccinated with anti-tumor vaccines or have received live
vaccines within 4 weeks before the first dose of study drug;
8. Major surgery or severe trauma within 4 weeks prior to the first use of study
drug.
3. Toxicity from previous anti-tumor therapy has not recovered to ≤ CTCAE grade 1
(except for toxicity judged by the investigator to have no safety risk);
4. Known hypersensitivity to any of the study treatments and their excipients;
5. Unable or unwilling to use folic acid or vitamin B12 injection;
6. Active autoimmune disease, history of autoimmune disease (including but not limited
to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis,
hyperthyroidism, hypothyroidism); except for:
1. Subjects with vitiligo or cured childhood asthma/allergies that do not require
any intervention after adulthood;
2. Subjects with autoimmune-mediated hypothyroidism treated with stable doses of
thyroid replacement hormone;
3. Subjects on stable doses of insulin for the treatment of type I diabetes
mellitus;
7. Have a history of immunodeficiency, including a positive HIV test, or have other
acquired or congenital immunodeficiency diseases, or have a history of organ
transplantation and allogeneic bone marrow transplantation, or autologous
hematopoietic stem cell transplantation;
8. Severe infection (CTCAE> grade 2) within 4 weeks before the first use of the study
drug, such as severe pneumonia requiring hospitalization, infection comorbidities,
etc., active lung inflammation on baseline chest imaging, symptoms and signs of
infection within 2 weeks prior to the first dose of the study drug requiring oral or
intravenous antibiotic treatment (except for prophylactic antibiotic use);
9. Confirmed or suspected history of interstitial lung disease or idiopathic pulmonary
fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or other moderate to
severe pulmonary diseases that seriously affect lung function (except for ≤ grade 1
radiation pneumonitis);
10. Subjects with active pulmonary tuberculosis infection found by medical history or CT
examination, or with a history of active pulmonary tuberculosis infection within 1
year prior to enrollment, or subjects with a history of active pulmonary
tuberculosis infection more than 1 year ago but without formal treatment;
11. Presence of active hepatitis B (hepatitis B virus surface antigen (HBsAg) positive
with HBV DNA ≥500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA
above the lower limit of detection of the analytical method);
12. Diagnosis of any other malignancy prior to the first dose of study drug, with the
exception of malignancies with low risk of metastasis (5-year survival rate >90%),
such as adequately treated basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix or breast, or adequately treated localized prostate cancer;
13. Pregnant or lactating women;
14. Uncontrolled intercurrent illness including, but not limited to: symptomatic
congestive heart failure, left ventricular ejection fraction (LVEF) <50%,
uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, major seizures,
superior vena cava syndrome, or psychiatric illness/social situation that may affect
study compliance, result in a significant increase in the risk of adverse events, or
affect the subject's ability to provide written informed consent;
15. As judged by the investigator, the subject has other factors that may lead to the
forced termination of the study, such as other serious diseases (including mental
illnesses) requiring concomitant treatment, serious abnormalities in laboratory test
values, and/or family or social factors that may affect the safety of the subject or
the collection of experimental data.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changshang
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu, doctorate
Phone:
13170419973
Email:
wulin-calf@vip.163.com
Investigator:
Last name:
Lin Wu, doctorate
Email:
Principal Investigator
Start date:
July 11, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Sponsor GmbH
Agency class:
Other
Source:
Shanghai Junshi Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06505837
