A phase II randomised trial investigating the benefit of adjuvant immunotherapy after neoadjuvant chemoimmunotherapy for resectable NSCLC (ADIL)

Conditions

Non Small Cell Lung Cancer (NSCLC)

Brief summary

Disease-free survival (DFS) is defined as time from surgery to local or distal recurrence, death due to lung cancer or censoring.

Detailed description

Disease-free survival (DFS) is defined as time from surgery to local or distal recurrence, death due to lung cancer or censoring., Overall survival (OS) is defined as time from surgery to death due to lung cancer or censoring., Proportion of patients with detection of ctDNA post-surgery and 12 months after surgery., Proportion of patients with maintained or improved level of health-related quality of life at 12 months after surgery., Proportion of patients with maintained or improved level of dyspnoea at 12 months after surgery., The primary outcome is the incremental cost-effectiveness ratio (ICER), defined as the incremental cost per quality-adjusted life year (QALY) gained in each treatment arm over a lifetime horizon from a Norwegian healthcare perspective. Secondary outcomes include overall QALYs gained and total costs - stratified by treatment arm., Adverse events grade 3-5.

Related papers

No related papers found yet.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS) is defined as time from surgery to local or distal recurrence, death due to lung cancer or censoring.	—

Secondary

Measure	Time frame
Disease-free survival (DFS) is defined as time from surgery to local or distal recurrence, death due to lung cancer or censoring., Overall survival (OS) is defined as time from surgery to death due to lung cancer or censoring., Proportion of patients with detection of ctDNA post-surgery and 12 months after surgery., Proportion of patients with maintained or improved level of health-related quality of life at 12 months after surgery., Proportion of patients with maintained or improved level of dyspnoea at 12 months after surgery., The primary outcome is the incremental cost-effectiveness ratio (ICER), defined as the incremental cost per quality-adjusted life year (QALY) gained in each treatment arm over a lifetime horizon from a Norwegian healthcare perspective. Secondary outcomes include overall QALYs gained and total costs - stratified by treatment arm., Adverse events grade 3-5.	—

Measure

Time frame

Disease-free survival (DFS) is defined as time from surgery to local or distal recurrence, death due to lung cancer or censoring., Overall survival (OS) is defined as time from surgery to death due to lung cancer or censoring., Proportion of patients with detection of ctDNA post-surgery and 12 months after surgery., Proportion of patients with maintained or improved level of health-related quality of life at 12 months after surgery., Proportion of patients with maintained or improved level of dyspnoea at 12 months after surgery., The primary outcome is the incremental cost-effectiveness ratio (ICER), defined as the incremental cost per quality-adjusted life year (QALY) gained in each treatment arm over a lifetime horizon from a Norwegian healthcare perspective. Secondary outcomes include overall QALYs gained and total costs - stratified by treatment arm., Adverse events grade 3-5.

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Outcome results

None listed