Can a Two-Drug combo outperform standard care in aggressive lung cancer?

NCT ID NCT07802821

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

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

Participants

About 556 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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 years and older

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. 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

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  1. The official record

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  2. A doctor treating you

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