Skyscraper-02/GO41767: A phase III, randomized, double-blinded, placebo-controlled study of atezolizumab plus carboplatin and etoposide with or without tiragolumab (anti-TIGIT antibody) in patients with untreated extensive-stage small cell lung cancer
Indication :

cancer du poumon à petites cellules non traité de stade avancé


Sponsor :

ROCHE


Phase :

III


Ligne :

première


Traitement :

tiragolumab vs placebo + atezolizumab + carboplatin + etoposide


Spécificités :
  • cancer du poumon à petites cellules de stade avancé histologiquement ou cytologiquement confirmé
  • pas de traitement systémique antérieur

Site :

CHUV


Contact(s) :
Solange Peters
Principal Investigator

CHUV
Oncology

Rue du Bugnon 46
Lausanne
1011

+41 21 314 44 62
solange.peters@chuv.ch

Primary objective :

Évaluer la sécurité et l’efficacité du tiragolumab en association avec l’atezolizumab et la chimiothérapie (carboplatine plus étoposide) comparativement à un traitement par placebo associé à l’atezolizumab (Tecentriq®) et chimiothérapie (carboplatine plus étoposide) chez les patients atteints d’un cancer du poumon à petites cellules non traité de stade avancé


Inclusion criteria :
  • Age > 18 years at time of signing Informed Consent Form
  • Ability to comply with the study protocol, in the investigator's judgment
  • ECOG performance status of 0 or 1 (see Appendix 10)
  • Histologically or cytologically confirmed ES-SCLC
  • No prior systemic treatment for ES-SCLC
  • For patients who have received prior chemoradiotherapy for limited-stage SCLC: must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
  • Measurable disease, as defined by RECIST v1.1
  • Submission of a pre-treatment tumor tissue sample
  • Adequate hematologic and end-organ function obtained within 14 days prior to randomization
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative HIV test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion criteria :
  • Symptomatic or actively progressing CNS metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >/=1 week prior to randomization
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled or symptomatic hypercalcemia
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
  • Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
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