To hear about similar clinical trials, please enter your email below
Trial Title:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial
NCT ID:
NCT06256237
Condition:
Limited Stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Etoposide
Conditions: Keywords:
small cell lung cancer
Toripalimab
JS004
Limited Stage
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All enrolled patients received toripalimab and JS004 Combined With etoposide and platinum
Chemotherapy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JS004
Description:
Specified dose on specified days.
Arm group label:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy
Other name:
tifcemalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Specified dose on specified days.
Arm group label:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy
Intervention type:
Procedure
Intervention name:
surgery
Description:
Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.
Arm group label:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Specified dose on specified days.
Arm group label:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy
Intervention type:
Drug
Intervention name:
Platinum
Description:
Specified dose on specified days.
Arm group label:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy
Summary:
For limited-stage small cell lung cancer (SCLC), neoadjuvant chemotherapy plus PD-1
antibody is recommended. However, most patients cannot achieve a complete pathological
response (CPR). A new immunotherapeutic strategy is needed to achieve a higher CPR rate.
JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains
immune cells' function and leads to immune escape of tumor cells. The combination of
PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial
aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and
JS004 plus etoposide and platinum Chemotherapy in limited-stage SCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage
confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Without systematic metastasis (including M1a, M1b and M1c);
9. Expected to be completely resected
10. Patients with lung function can tolerate surgery
11. Fertile female patients must voluntarily use effective contraceptives not less than
120 days after chemotherapy or the last dose of toripalimab (whichever is later)
during the study period, and urine or serum pregnancy test results within 7 days
prior to enrollment are negative.
12. Unsterilized male patients must voluntarily use effective contraception during the
study period not less than 120 days after chemotherapy or the last dose of
toripalimab (whichever is later).
Exclusion Criteria:
1. Participants who have received any systemic anti-cancer treatment for thymic
epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug
treatment, targeted drug treatment and experimental treatment;
2. Patients with a malignancy other than SCLC within five years prior to the start of
this trial;
3. Participants with any unstable systemic disease (including active infection,
uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in
the last three months, congestive heart failure (>= NYHA) Grade II), myocardial
infarction (6 months before admission), severe arrhythmia requiring drug treatment,
liver, kidney or metabolic diseases;
4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome
requiring systemic treatment;
5. Participants who are allergic to the test drug or any auxiliary materials;
6. Participants with Interstitial lung disease currently;
7. Participants with active hepatitis B, hepatitis C or HIV;
8. Pregnant or lactating women;
9. Any malabsorption;
10. Participants suffering from nervous system diseases or mental diseases that cannot
cooperate
11. Other factors that researchers think it is not suitable for enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, PhD
Email:
zhangpeng1121@tongji.edu.cn
Start date:
April 1, 2024
Completion date:
January 31, 2032
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06256237
