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New drug combo aims to shrink tough lung tumors

NCT ID NCT07697586

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This phase II trial is testing whether a combination of two drugs, SKB264 and SKB118, can safely shrink tumors in people with advanced non-small cell lung cancer that has spread. The study includes a dose-finding phase and an expansion phase to better understand the treatment's effects. Participants must have a specific type of lung cancer without certain gene mutations and be in generally good health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacituzumab tirumotecan (SKB264) and SKB118
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced non-small cell lung cancer who have limited alternatives.
What could go wrong
This is an early phase II trial, so the combination may not prove effective or could cause significant side effects. Results may not apply to all patients.

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 206 people

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

Started

Aug 2026

Expected to finish

Aug 2029

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: * Histologically or cytologically confirmed locally advanced or metastatic NSCLC * Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene. * Provide a tumor tissue sample. * At least one measurable lesion as assessed by the investigator according to RECIST v1.1. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks. * Adequate bone marrow, liver, kidney, and coagulation function. * Male and female participants must agree to use highly effective methods of contraception during the specified period of the study. Exclusion Criteria: * Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components. * Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS). * Uncontrolled systemic disease as judged by the investigator. * Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites. * Presence of other moderate to severe lung disorders. * History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks. * Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications. * Active hepatitis b or hepatitis c or co-infection with HBV and HCV. * Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation. * Known hypersensitivity to the study drug or any of its components. * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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

  • Jilin Cancer Hospital

    NOT_YET_RECRUITING

    Jilin City, China

  • Shanghai East Hospital, Tongji University

    RECRUITING

    Shanghai, China

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