Actively Recruiting
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-05-29
30
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the Informed Consent Form.
- Age 18 years or older.
- Diagnosis of small cell lung cancer (SCLC) confirmed by biopsy and limited stage confirmed by imaging (CT, PET-CT, or EBUS).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable tumor lesion according to RECIST 1.1.
- Good function of major organs including liver, kidney, and blood system.
- No systemic metastasis (including M1a, M1b, and M1c).
- Tumor expected to be completely resectable.
- Lung function adequate to tolerate surgery.
- Fertile female patients must agree to use effective contraception for at least 120 days after chemotherapy or the last dose of toripalimab, and have a negative pregnancy test within 7 days before enrollment.
- Unsterilized male patients must agree to use effective contraception during the study and for at least 120 days after chemotherapy or the last dose of toripalimab.
You will not qualify if you...
- Prior systemic anti-cancer treatment for thymic epithelial tumor, including surgery, radiotherapy, cytotoxic drugs, targeted therapy, or experimental treatment.
- Malignancy other than SCLC within the past five years.
- Unstable systemic diseases such as active infections, uncontrolled hypertension, unstable angina, recent angina, congestive heart failure (Grade II or higher), recent myocardial infarction, severe arrhythmia requiring treatment, or serious liver, kidney, or metabolic diseases.
- Active or suspected autoimmune disease or autoimmune paracancer syndrome requiring systemic treatment.
- Allergies to the study drugs or any of their components.
- Current interstitial lung disease.
- Active hepatitis B, hepatitis C, or HIV infection.
- Pregnant or breastfeeding women.
- Any malabsorption conditions.
- Nervous system or mental disorders preventing cooperation.
- Other factors deemed unsuitable for participation by the researchers.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
P
Peng Zhang, PhD
CONTACT
T
Tao Ge, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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