lung cancer non small-cell lung cancer
Conditions
Interventions
Patients will receive (unless there is unacceptable toxicity, withdrawal of
consent, or another discontinuation criterion is
met):
* treatment group 1: patients receive (via IV infusion) 1500 mg durv
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically confirmed NSCLC with resectable stage II-III disease who have undergone curative intent therapy (complete resection of the primary tumor ± neoadjuvant and/or adjuvant therapy) per SoC • A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal glands) along with brain MRI must have been done for surgical planning prior to surgery • Complete resection of the primary NSCLC is mandatory • Patients should have completed curative intent therapy • Confirmation of suitable resected tumor tissue and whole blood sample • Post-adjuvant therapy or post-operative CT scan of the chest and abdomen and brain MRI • Consents to be accessible for q6w plasma sample collection for MRD evaluation and for q12w CT scans during the 96-week surveillance period Inclusion criteria for second screening period: • CT scan of the chest and abdomen and brain MRI performed within the 28 days prior to randomization to confirm no evidence of RECIST 1.1-defined disease recurrence and/or metastasis • Complete post-operative wound healing • Must have recovered from all acute, reversible toxic effects from chemotherapy • Adequate organ and marrow function • Must have a life expectancy of at least 12 weeks
Exclusion criteria
Exclusion criteria: Unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence • EGFR-mutant and/or ALK-translocation • Mixed small cell and NSCLC histology • Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice. • Active or prior documented autoimmune or inflammatory disorders • Uncontrolled intercurrent illness (see protocol page 67) • History of another primary malignancy (check for exceptions) • History of active primary immunodeficiency • Active infection including tuberculosis, hepatitis B, hepatitis C virus or HIV • Received any IO therapy in the adjuvant setting or any prior exposure to durvalumab • Received any radiotherapy in the neoadjuvant setting • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment (with exceptions) • Current or prior use of immunosuppressive medication within 14 days before the first dose of IP (with exceptions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC>=1% analysis set | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC>=1% analysis set and in all randomized patients To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC>=1% analysis set and in all randomized patients To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo To investigate the relationship between a patient*s baseline PD-L1 TC expression and efficacy of study treatments | — |
Countries
Netherlands
Outcome results
None listed