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New hope for lung cancer patients who stopped responding to targeted therapy

NCT ID NCT05870319

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new drug called SKB264 against standard chemotherapy in 376 adults with advanced non-small cell lung cancer that has an EGFR mutation and has stopped responding to targeted therapy. The goal is to see if SKB264 can slow cancer growth better than chemo. Participants receive either SKB264 alone or a chemo combination.

What this could mean

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

Active substance
SKB264 (a drug given by IV infusion)
What this could lead to
If it works, this could offer a new treatment option for people with a common type of lung cancer that has stopped responding to current targeted therapies.
What could go wrong
This is a late-stage trial, but the drug is still experimental. It may not prove better than standard chemo, and side effects are possible. 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

376 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Sep 2026

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. Males or females aged ≥18 to ≤75 years at the time of signing the ICF; 2. Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy; 3. EGFR-sensitive mutations; 4. Failure of prior EGFR-TKI therapy; 5. At least one measurable target lesion per RECIST 1.1 as assessed by the investigator; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Expected survival ≥12 weeks; 8. Adequate organ and bone marrow function; 9. Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; 10. Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures Exclusion Criteria: 1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%; 2. Other malignancies within 3 years prior to the first dose; 3. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis; 4. Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed; 5. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria; 6. Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 7. Prior TROP2-targeted therapy; 8. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs); 9. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study; 10. Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; 11. Pregnant or lactating women;

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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.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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