New hope for lung cancer: experimental combo targets tough tumors
NCT ID NCT07296809
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug combination (SKB500) in 80 adults with small cell lung cancer, a fast-growing type of lung cancer. The goal is to see if the treatment is safe and can shrink tumors or slow the disease. Participants must be 18-75 and have extensive-stage cancer, with some having had prior treatment and others not.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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. Male or female participants between 18 and 75 years old. 2. Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC): * Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage. * Cohort 2\~3: participant has received no prior systemic treatment. 3. Agree to provide fresh or archival tumor tissue for biomarker analysis. 4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy \>= 12 weeks. 7. Has adequate organ and bone marrow functions. 8. Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities. 9. Effective contraceptive methods should be used during the study and for 6 months after the end of treatment. 10. Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures. Exclusion Criteria: 1. The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components. 2. Has previously received medications with the same target or the same toxins. 3. Presence of spinal cord compression or clinically active central nervous system metastases. 4. Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels. 5. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose. 6. With peripheral neuropathy of grade ≥ 2. 7. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions. 8. Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc. 9. Serious or uncontrolled heart disease or clinical symptoms requiring treatment. 10. History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis. 11. Clinical severe lung damage caused by concurrent lung disease. 12. Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion. 13. Pregnant or lactating women. 14. Rapid disease deterioration in the screening process.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, China
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