A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment… (NCT07009457) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
China24 participantsStarted 2025-06-16
Plain-language summary
This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. ECOG physical fitness score 0-1 points.
. According to RECIST v1.1, there must be at least one measurable tumor lesion.
. Expected survival time ≥ 12 weeks.
. Having sufficient bone marrow and organ function.
. Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SHR-1316 serum trough concentration (Ctrough)
Timeframe: Day1 pre-dose to Day28.
2
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
Timeframe: Day1 pre-dose to Day21.
3
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
. Patients with central nervous system or meningeal metastases.
. Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
. Patients diagnosed by researchers with uncontrollable tumor related pain.
. 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.
. 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.
. 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).
. 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.
. 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.