New hope for lung cancer patients who stopped responding to targeted therapy
NCT ID NCT05870319
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
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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 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.
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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