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Cholesterol-Lowering drug may boost lung cancer immunotherapy

NCT ID NCT07061535

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

    RECRUITING

    Hangzhou, Zhejiang, China

  • First Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, China

  • Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, China

  • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science

    RECRUITING

    Jinan, Shandong, China

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