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New drug shows promise in lung cancer fight

NCT ID NCT07019675

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called SKB518 in 192 adults with lung cancer (non-small cell or small cell). The goal is to see if it shrinks tumors and to check for side effects. Participants receive the drug alone until their disease gets worse or side effects become too severe.

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 192 people

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

Started

Aug 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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.

Inclusion Criteria: 1. Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females. 2. Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology. 3. At least one measurable tumor lesion per RECIST v1.1. 4. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 5. Expected survival period ≥ 12 weeks. 6. The function of important organs meets the requirements of the protocol. Exclusion Criteria: 1. Symptomatic or uncontrolled cardiovascular disease 2. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD; 3. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose. 4. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 5. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

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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

    17 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

  • Affiliated Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, China

  • Cancer Hospital Chinese Academy of Medical Science

    RECRUITING

    Beijing, China

  • Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, China

  • Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, Guangdong, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

  • Shanghai Pulmonary Hospital (Affiliated to Tongji University)

    RECRUITING

    Shanghai, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.