Can a Two-Drug combo outperform standard care in aggressive lung cancer?
NCT ID NCT07802821
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase III trial compares an experimental combination of two drugs, QLC5508 and QL2107, against the current standard treatment (tislelizumab plus chemotherapy) as a first-line therapy for people with extensive-stage small cell lung cancer. The study enrolls adults who have not received prior systemic treatment for this cancer. Researchers measure how long participants live overall and how long before the cancer progresses, aiming to see if the new combo offers a meaningful benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLC5508 combined with QL2107, two experimental drugs given by IV infusion every three weeks
- What this could lead to
- If this combination works, it could offer a new first-line treatment option that extends survival for people with extensive-stage small cell lung cancer.
- What could go wrong
- This is an early-stage comparison in a specific patient group, and the experimental combination may not prove more effective or safer than the current standard. Side effects from the drugs are possible.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
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 years and older
- 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. Age ≥18 years. 2. Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system. 3. No prior systemic treatment for ES-SCLC. 4. At least one extracranial measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment. 6. Life expectancy ≥12 weeks. 7. Has adequate organ function. 8. Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy. 9. Voluntarily sign the written informed consent form and comply with the protocol requirements. Exclusion Criteria: 1. Has received or undergoing any of the following treatment: Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors. 2. Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology. 3. Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression. 4. Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment. 5. Major surgery within 4 weeks prior to the study treatment. 6. Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy. 7. Previous or concurrent primary malignancies. 8. History of severe heart disease or cerebrovascular disease. 9. History of Severe or uncontrolled hypertension or diabetes mellitus. 10. Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening. 11. Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity. 12. Known history of pre-existing or newly diagnosed autoimmune disease. 13. History of severe neuropathy or mental disorders. 14. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs. 15. Unlikely to comply with study procedures and requirements in the opinion of the investigator. 16. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
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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 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.
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Other studies related to the condition(s) this trial covers.
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