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Eine offene Phase-III-Studie zur Erhaltungstherapie mit Lurbinectedin in Kombination mit Atezolizumab im Vergleich zu Atezolizumab bei Teilnehmenden mit kleinzelligem Lungenkrebs im fortgeschrittenen Stadium
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (IMforte)
- Krebs
- Lungenkrebs
- Kleinzelliger Lungenkrebs
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Aktiv, keine Rekrutierung
Diese Studie läuft in
Städte
- Bad Berka
- Berlin
- Chemnitz
- Essen
- Gauting
- Georgsmarienhütte
- Großhansdorf
- Halle (Saale)
- Hannover
- Immenhausen
- Lübeck
- Regensburg
Studien-ID:
NCT05091567 GO43104
Studienzusammenfassung
Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05091567,GO43104
Studien-ID
Atezolizumab, Lurbinectedin, Carboplatin, Etoposide
Treatments
Small-Cell Lung Cancer
Condition
Official Title
A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
Inclusion Criteria for the Induction Phase:
- ECOG PS of 0 or 1
- No prior systemic therapy for ES-SCLC
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
- Histologically or cytologically confirmed ES-SCLC
- Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
- Measurable disease, as defined by RECIST v1.1
- Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
Inclusion Criteria for the Maintenance Phase:
- ECOG PS of 0 or 1
- Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
- Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1
- Adequate hematologic and end-organ function
Exclusion Criteria
Exclusion Criteria for the Induction Phase:
- Presence or history of CNS metastases
- Active or history of autoimmune disease or deficiency
- History of malignancies other than SCLC within 5 years prior to enrollment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Treatment with investigational therapy within 28 days prior to enrollment
- Presence or history of CNS metastases
- Receiving consolidative chest radiation
- Severe infection within 2 weeks prior to randomization into the maintenance
- Treatment with therapeutic oral or IV antibiotics at the time of randomization
Exclusion Criteria for the Maintenance Phase:
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