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Die klinische Studie NCT06001151 (ACHELOUS) für Nicht-kleinzelliges Lungenkarzinom ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative (ACHELOUS) Phase 2 49 Multizentrisch Kombinationstherapie

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Die klinische Studie NCT06001151 (ACHELOUS) untersucht Behandlung im Zusammenhang mit Nicht-kleinzelliges Lungenkarzinom. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 7. August 2023. Es ist geplant, 49 Teilnehmer aufzunehmen. Durchgeführt von Qian Chu wird der Abschluss für 31. August 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. August 2023 aktualisiert.
Kurzbeschreibung
This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.
Ausführliche Beschreibung
This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy. The primary endpoint is 12-month progression...Mehr anzeigen
Offizieller Titel

Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative：A Multi-center, Single-arm, Phase II Study

Erkrankungen
Nicht-kleinzelliges Lungenkarzinom
Weitere Studien-IDs
  • ACHELOUS
  • S019
NCT-Nummer
NCT06001151
Studienbeginn (tatsächlich)
2023-08-07
Zuletzt aktualisiert
2023-08-21
Studienende (vorauss.)
2027-08-31
Geplante Rekrutierung
49
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
non-squamous Non-Small Cell Lung Cancer
Programmed Cell Death Ligand 1
cadonilimab
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellExperimental Arm
Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy.
Cadonilimab
Patients receive cadonilimab (10mg/kg) every 3 weeks.
Pemetrexed
Patients receive pemetrexed (500mg/m2) every 3 weeks.
Carboplatin
Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
12-month progression-free-survival (PFS) rate
Rate of patients with complete/partial response at 12-month from enrollment
At 12 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
objective response rate (ORR)
objective response rate using RECIST 1.1 criteria
about 24 months
duration of response (DOR)
Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause
about 24 months
disease control rate (DCR)
disease control rate using RECIST 1.1 criteria
about 24 months
time to response (TTR)
Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)
about 24 months
progression free survival (PFS)
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
about 24 months
overall survival (OS)
Time from enrollment until death due to any cause
about 24 months
incidence, type and severity of adverse events
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
  • PD-L1 TPS<1%
  • Life expectancy more than 3 months
  • Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
  • Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
  • ECOG score 0-1
  • Patients must have at least one measurable lesion according to RECIST 1.1
  • Has adequate organ function
  • Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
  • Voluntarily sign a written informed consent form

  • Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
  • With active central nervous system (CNS) metastases confirmed by CT or MRI
  • With other malignancy within 3 years before enrollment
  • With severe infections within 4 weeks of the first dose of study treatment
  • Women who are pregnant or lactating
  • History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
  • History of myocarditis, cardiomyopathy, and malignant arrhythmia
  • Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
  • Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
  • Active autoimmune diseases that require systematic treatment within 2 years before enrollment
  • History of Human Immunodeficiency Virus (HIV)
  • With active hepatitis B infection
  • With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Qian Chu logoQian Chu
Verantwortliche Partei
Qian Chu, Prüfsponsor, Professor, Tongji Hospital
Zentrale Studienkontakte
Kontakt: Qian Chu, 13212760751, [email protected]
1 Studienstandorte in 1 Ländern

Hubei

Qian Chu, Wuhan, Hubei, 430030, China
Qian Chu, Kontakt, 13212760751, [email protected]
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