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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

30. August 2026 aktualisiert von: Qilu Pharmaceutical Co., Ltd.

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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

556

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: QLC5508 in combination with QL2107
QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years.
Aktiver Komparator: Tislelizumab in Combination with Platinum-based Chemotherapy
Tislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall survival (OS)
Zeitfenster: Up to approximately 36 months
OS is defined as the duration from the date of randomization to the date of death due to any cause.
Up to approximately 36 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free survival (PFS)
Zeitfenster: Up to approximately 36 months
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
Up to approximately 36 months
Objective response rate (ORR)
Zeitfenster: Up to approximately 36 months
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
Up to approximately 36 months
Duration of response (DOR)
Zeitfenster: Up to approximately 36 months
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Up to approximately 36 months
Disease control rate (DCR)
Zeitfenster: Up to approximately 36 months
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
Up to approximately 36 months
6-month PFS rate
Zeitfenster: Up to approximately 36 months
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
Up to approximately 36 months
12-month PFS rate
Zeitfenster: Up to approximately 36 months
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
Up to approximately 36 months
12-month OS rate
Zeitfenster: Up to approximately 36 months
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
Up to approximately 36 months
24-month OS rate
Zeitfenster: Up to approximately 36 months
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
Up to approximately 36 months
Treatment Emergent Adverse Event (TEAE)
Zeitfenster: Up to approximately 36 months

TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment.

TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.

Up to approximately 36 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Oktober 2026

Primärer Abschluss (Geschätzt)

15. März 2029

Studienabschluss (Geschätzt)

15. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

30. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. August 2026

Zuerst gepostet (Tatsächlich)

3. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

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