QLC5508 plus QL2107 vs tislelizumab plus platinum chemotherapy as first treatment for extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter phase 3 study comparing two first-line regimens for extensive-stage small cell lung cancer. Participants will be assigned to receive QLC5508 with QL2107 or tislelizumab with platinum and etoposide. The study will evaluate efficacy and safety as initial therapy in eligible adults. Key eligibility includes confirmed ES-SCLC, no prior systemic treatment, measurable disease, good performance status, and adequate organ function. The trial is sponsored by Qilu Pharmaceutical with Shanghai East Hospital as a participating site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Haiying Yu, Bachelor
• Email: haiying.yu@qilu-pharma.com
• Phone: +86-17821799566

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tislelizumab use in European patients with NSCLC or ES-SCLC in routine care

  This study looks at how tislelizumab is used in real-world European patients with advanced NSCLC or extensive-stage SCLC and what outcomes are seen in everyday clinical practice.

  Recruiting at 6 sites BeOne Medicines · Córdoba and 5 other locations · NCT07652736

• BL-B01D1 plus tislelizumab vs platinum-based chemo plus tislelizumab as first-line treatment for extensive-stage small cell lung cancer

  This trial tests whether adding BL-B01D1 to tislelizumab works better than platinum-containing chemotherapy with tislelizumab for adults with extensive-stage small cell lung cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Zhengzhou, Henan and 1 other locations · NCT07502300

• Using T-cell receptor patterns to predict response to first-line tislelizumab plus chemotherapy in extensive-stage small-cell lung cancer

  This will test whether patterns in patients' T-cell receptors can predict how well first-line tislelizumab plus chemotherapy works for people with extensive-stage small-cell lung cancer.

  Recruiting Henan Cancer Hospital · Zhengzhou, Henan · NCT07244016

• Combining Tislelizumab with chemotherapy and radiotherapy for extensive-stage small-cell lung cancer

  This study is testing if combining a new drug called Tislelizumab with chemotherapy and radiation can help people with extensive-stage small-cell lung cancer feel better and improve their health.

  Recruiting at 6 sites Phase 2 Second Hospital of Shanxi Medical University · Jincheng, Shanxi and 5 other locations · NCT06536868

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.