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Trial Title:
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer
NCT ID:
NCT06648200
Condition:
Small Cell Lung Cancer Extensive Stage
Small Cell Lung Cancer Recurrent
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Etoposide
Conditions: Keywords:
small cell lung cancer
Toripalimab
JS004
Extensive-stage
Recurrent
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
All enrolled patients were randomly assigned to one of two groups. Patients in group 1
received toripalimab combined with etoposide and platinum Chemotherapy; patients in group
2 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:
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
Other name:
tifcemalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Specified dose on specified days.
Arm group label:
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
Arm group label:
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Specified dose on specified days.
Arm group label:
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
Arm group label:
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
Intervention type:
Drug
Intervention name:
Platinum
Description:
Specified dose on specified days.
Arm group label:
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
Arm group label:
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
Summary:
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or
carboplatin) combined with etoposide as the first-line treatment is recommended. However,
the recurrence rate is extremely high after the initial first-line treatment. For those
who relapse or progress within more than six minths after the end of the-first-line
treatment, chose the current guideline recommendation trearment plan has the poor
prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor
effects. 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 combined with platinum-based doublet chemotherapy in
extensive-stage SCLC or relapsed within more than six months after radical treatment
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 or EBUS, and
extensive stage or recurrent confirmed by imageological examinations or relapsed
within more than six months after radical treatment SCLC;
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. Fertile female patients must voluntarily use effective contraceptives from the start
of the trial to within 30 days after its completion, and urine or serum pregnancy
test results within 7 days prior to enrollment are negative;
9. Unsterilized male patients must voluntarily use effective contraception during the
trial period and for 30 days after its conclusion.
Exclusion Criteria:
1. Patients with a malignancy other than SCLC within five years prior to the start of
this trial;
2. Participants with any unstable systemic disease (including uncontrolled
hypertension, severe arrhythmia, etc.);
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome
requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with active hepatitis B, hepatitis C or HIV;
6. Participants with Interstitial lung disease currently;
7. Pregnant or lactating women;
8. Any malabsorption;
9. Participants suffering from nervous system diseases or mental diseases that cannot
cooperate;
10. 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
Contact:
Last name:
Peng Zhang, PhD
Email:
zhangpeng1121@tongji.edu.cn
Start date:
November 1, 2024
Completion date:
September 1, 2030
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/NCT06648200
