Can a targeted drug combo outperform standard care for aggressive lung cancer?
NCT ID NCT07796100
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether the experimental drug ZL-1310, when combined with an immunotherapy drug, can help people with extensive-stage small cell lung cancer live longer than those receiving standard chemotherapy plus immunotherapy. The study enrolls about 530 adults who have not yet received systemic treatment for their cancer. Participants are randomly assigned to receive either the new combination or the standard care, and researchers will compare overall survival and other outcomes like tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZL-1310, an antibody-drug conjugate, combined with an immunotherapy drug (atezolizumab or durvalumab)
- What this could lead to
- If it works, this combination could become a new first-line treatment option for extensive-stage small cell lung cancer, potentially improving survival compared to current standard care.
- What could go wrong
- This is a phase 3 trial, but the drug is still experimental. It may not prove more effective than standard chemotherapy plus immunotherapy, and antibody-drug conjugates can cause side effects like fatigue, nausea, or blood-related issues.
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 530 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
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: * Histologically or cytologically confirmed ES-SCLC * No prior systemic therapy has been received * Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy * Eastern Cooperative Oncology Group performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate organ and marrow function Exclusion Criteria: * Has a contraindication to receive atezolizumab or durvalumab according to local drug label or local treatment guideline * Participants with symptomatic CNS metastases (require initiation or dose change of steroids or anti-convulsant within 7 days prior to randomization; require steroid dose higher that prednisone 10 mg/day or equivalent within 14 days prior to randomization * History of ILD/pnuemonitis (non-infectious) that required corticosteroids, current ILD/pnuemonitis of any grade, or suspected ILD/pnuemonitis that cannot be ruled out by imaging at screening * Received radiotherapy within 2 weeks to the non-thoracic and within 4 weeks to the thoracic area prior to the first dose of study treatment or received more than 30 Gy of thoracic radiotherapy * Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment * Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of \<90% on room air) resulting from intercurrent pulmonary illnesses * Major surgery within 4 weeks prior to the first dose of study treatment.
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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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