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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer (NCT07009457) is a Phase 1 interventional studying Widespread Small Cell Lung Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Widespread Small Cell Lung Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form to this study prior to the trial and voluntarily sign a written willing to sign a consent form 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SHR-1316 (sc) Injection

SHR-1316 (sc) injection.

DRUG

SHR-1316 Injection

SHR-1316 injection.

DRUG

Carboplatin Injection

Carboplatin injection.

DRUG

Etoposide Injection

Etoposide injection.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07009457), the sponsor (Suzhou Suncadia Biopharmaceuticals Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07009457 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07009457?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07009457?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07009457. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07009457. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.