Compares QLC5508 with QL2107 against standard treatment in new lung cancer
Tests QLC5508 with QL2107 in adults newly diagnosed with extensive-stage small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive-stage small cell lung cancer who have not yet had any drug treatment for it. It compares QLC5508 with QL2107 against tislelizumab with platinum-based chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Extensive-stage small cell lung cancer, confirmed by tissue or cell tests, with at least one measurable tumour outside the brain.
- Earlier treatment
- No earlier drug (systemic) treatment for extensive-stage small cell lung cancer.
Main reasons for not taking part
- Earlier or current B7-H3 targeted therapy or topoisomerase I inhibitor treatment
- Transformed or mixed small cell and non-small cell lung cancer
- Active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression
- Known or suspected interstitial lung disease or non-infectious pneumonitis
- Known history of autoimmune disease
Read by machine on 9 November 2026.
Where in China
- Shanghai East HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT07802821
- Record updated
- 30 October 2026
- Original description
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.Read full original descriptionShow less
A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
Inclusion: Age ≥18 years; 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; No prior systemic treatment for ES-SCLC; At least one extracranial measurable lesion according to RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment; Life expectancy ≥12 weeks; Has adequate organ function; Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy; Voluntarily sign the written informed consent form and comply with the protocol requirements.
Exclusion: 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; 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; Major surgery within 4 weeks prior to the study treatment; Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy; Previous or concurrent primary malignancies; Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening; History of severe heart disease or cerebrovascular disease; History of Severe or uncontrolled hypertension or diabetes mellitus; 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; Known history of pre-existing or newly diagnosed autoimmune disease; History of severe neuropathy or mental disorders; History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs; Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments; 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; Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression; Unlikely to comply with study procedures and requirements in the opinion of the investigator.