Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for patients with extensive stage small cell lung cancer, which is a type of lung cancer that has spread widely in the body. The study will look at how well a drug called SHR-1316, given under the skin, works when combined with two chemotherapy drugs, carboplatin and etoposide. Researchers want to find out how safe the treatment is and if it can effectively help reduce tumors.

To be eligible for this trial, patients need to be between 18 and 75 years old, have confirmed extensive stage small cell lung cancer, and should not have received prior treatment for it. Participants should also be in good overall health, meaning they can perform daily activities with little to no assistance. If someone decides to join the study, they will be closely monitored by healthcare professionals throughout the treatment to ensure their safety and well-being. It’s important to know that this trial is not yet recruiting participants, so there will be no immediate commitment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
• • 2. ECOG physical fitness score 0-1 points.
• • 3. According to RECIST v1.1, there must be at least one measurable tumor lesion.
• • 4. Expected survival time ≥ 12 weeks.
• • 5. Having sufficient bone marrow and organ function.
• • 6. Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
• • Exclusion Criteria
• • 1. Patients with central nervous system or meningeal metastases.
• • 2. Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
• • 3. Patients diagnosed by researchers with uncontrollable tumor related pain.
• • 4. Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.
• • 5. Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
• • 6. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically significant active pneumonia at screening; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may participate in this study).
• • 7. Severe infections, including but not limited to bacteremia requiring hospitalization and severe pneumonia, were present within 4 weeks prior to the first medication; Within 2 weeks prior to the first medication, there is an active infection with CTCAE ≥ 2 that requires treatment with systemic antibiotics.
• • 8. Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment.
• • 9. History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
• • 10. Known to have alcohol or drug dependence; Individuals with mental disorders or poor compliance; Pregnant or lactating women; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make it unsuitable to participate in this clinical study.