Stage IIB-IIIB (N2) resectable non small cell lung cancer
Conditions
Brief summary
DFS in patients without pCR, measured from randomisation.
Detailed description
Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0., Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation.
Interventions
DRUGPEMETREXED
DRUGGEMCITABINE
DRUGPACLITAXEL
DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
ETOP IBCSG Partners Foundation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS in patients without pCR, measured from randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0., Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation. | — |
Countries
Austria, Belgium, Estonia, France, Ireland, Italy, Netherlands
Outcome results
None listed