Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedStudy Start
First participant enrolled
June 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
ExpectedJuly 4, 2025
July 1, 2025
3 months
May 29, 2025
July 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
SHR-1316 serum trough concentration (Ctrough)
Day1 pre-dose to Day28.
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
Day1 pre-dose to Day21.
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
Day1 pre-dose to Day28.
Secondary Outcomes (9)
Maximum Concentration of SHR-1316 (sc) (Cmax)
Day1 pre-dose to Day28.
Time to maximum plasma concentration (Tmax)
Day1 pre-dose to Day28.
Terminal half-life (t1/2)
Day1 pre-dose to Day28.
Incidence and severity of adverse events (AEs)
About 2 years.
Objective Response Rate (ORR)
About 2 years.
- +4 more secondary outcomes
Study Arms (3)
SHR-1316 (sc) Dose A Group
EXPERIMENTALSHR-1316 (sc) Dose B Group
EXPERIMENTALSHR-1316 (sc) Dose C Group
EXPERIMENTALInterventions
SHR-1316 (sc) injection.
SHR-1316 injection.
Carboplatin injection.
Etoposide injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2025
First Posted
June 6, 2025
Study Start
June 16, 2025
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2028
Last Updated
July 4, 2025
Record last verified: 2025-07