PACIFIC-4 Studie
multizentrisch
Kombination der SBRT mit einer Immuntherapie (Durvalumab) bei medizinisch inoperablen Patienten oder bei Ablehnung einer Operation
Zusammenfassung
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab versus placebo following SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.
Einschlusskriterien
- Age ≥18 years
- Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
- Completion of SoC SBRT as definitive treatment prior to randomization
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Body weight >30 kg
- Tumor sample required
- Adequate organ and marrow function required
- Patients with central or peripheral lesions are eligible
- Staging studies must be done within 8 weeks before randomization
Ausschlusskriterien
- Mixed small cell and non-small cell cancer histology
- History of allogeneic organ transplantation
- History of another primary malignancy with exceptions
- History of active primary immunodeficiency
- Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥2 from SBRT (Stereotactic Body Radiation Therapy)