Cholesterol-Lowering drug may boost lung cancer immunotherapy
NCT ID NCT07061535
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding tafolecimab (a cholesterol-lowering drug) to standard chemotherapy and the immunotherapy sintilimab helps people with extensive-stage small cell lung cancer live longer without their cancer growing. About 40 adults who have not had prior treatment for this advanced lung cancer will receive all three drugs together. The study measures how long the cancer stays under control and how well patients respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab, tafolecimab, etoposide, carboplatin or cisplatin
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that improves how long people with extensive-stage small cell lung cancer live without their disease worsening.
- What could go wrong
- This is an early-phase, single-arm trial with only 40 participants, so results may not apply broadly. Adding tafolecimab to standard therapy may increase side effects without clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Age ≥18 years, ECOG performance status 0-1; * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria; * Previously not receiving systemic treatment for ES-SCLC; * Greater than or equal to 1 measurable lesion exists according to RECIST v1.1; * Expected survival \>= 12 weeks; * Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing). Key Exclusion Criteria: * Previously receiving systemic anti-tumor therapy for ES-SCLC; * Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination; * Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form; * Receiving systemic immunostimulant treatment within 4 weeks before enrollment; * Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed); * Severe cardiovascular disease; * Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment; * Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection; * Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases; * Pregnancy or lactation; * Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment; * Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion; * Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment; * Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide; * Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment; * Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin) * Uncontrolled or symptomatic hypercalcemia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
RECRUITINGHangzhou, Zhejiang, China
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First Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, China
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Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, China
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Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science
RECRUITINGJinan, Shandong, China
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Other studies related to the condition(s) this trial covers.
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- Can a pill help keep advanced lung cancer at bay?
- Can a Two-Drug attack shrink tough lung cancers?
- Could adding chemo to tarlatamab overcome resistance in lung cancer?
- Can a smartphone app ease the burden of advanced lung cancer?