Actively Recruiting
Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC
Led by Sichuan University · Updated on 2026-05-05
45
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.
CONDITIONS
Official Title
Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 75 years
- Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC)
- No prior treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Positive SLFN-11 detected by immunohistochemistry on five unstained paraffin slides
- Extensive clinical stage (AJCC 8th edition Stage IV with lesions exceeding one side of the chest or including malignant effusions or hematogenous metastases) or large/multiple lung nodules suitable for tolerable radiotherapy
- Suitable for combination of etoposide, cisplatin chemotherapy, and low-dose radiotherapy as first-line treatment
- At least one measurable lesion 10 mm by CT or MRI suitable for repeat measurement
- Patients with brain metastases must be asymptomatic or stable on steroids and anticonvulsants for at least 1 month prior
- No previous immune checkpoint inhibitors or PARP inhibitors; no prior chemotherapy or radiation to chest lesion
- Weight over 30 kg
- Life expectancy at least 12 weeks
- Adequate organ and bone marrow function
- Able and willing to comply and provide informed consent
- Effective contraception use for men and women with childbearing potential during treatment and specified periods after last doses
You will not qualify if you...
- Mixed small cell lung cancer or non-small cell lung cancer diagnosis
- Limited stage small cell lung cancer
- Poorly controlled malignant pleural or pericardial effusions needing continuous drainage
- Active or symptomatic brain or leptomeningeal metastases
- Prior systemic antitumor therapy or immune checkpoint inhibitors for SCLC
- Active unstable systemic diseases including infections, autoimmune or inflammatory diseases, severe heart failure, angina, coronary syndrome, severe arrhythmia, severe liver, kidney or metabolic disease, or HIV infection
- Previous allogeneic stem cell or solid organ transplant
- Prior or active interstitial lung disease or pneumonia requiring immunosuppressive therapy
- Severe infection or antibiotic treatment within specified recent periods
- Diagnosis or treatment for another malignancy within 5 years (except certain skin or in situ carcinomas)
- Pregnancy, lactation, or refusal to use effective contraception
- Allergy to study drugs or components
- Investigator judgment of inability to comply or complete study
- Inadequate bone marrow or vital organ function
- Concurrent participation in other clinical trials (except observational or follow-up studies)
- Unsuitable for etoposide-cisplatin chemotherapy, sugemalimab or olaparib
- History of thoracic radiotherapy or planned intensive thoracic radiotherapy prior to systemic therapy (palliative radiotherapy allowed if completed prior)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
M
Min, Yu, MD
CONTACT
Y
You, Lu, MD
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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