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A
Scorecard version: 1

Indication details

Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour stage
Neoadjuvant
Combined Agent(s)
Platinum-doublet ChT
Control Arm
Platinum-doublet ChT
Treatment Setting
Treatment of adult patients with resectable non-small cell lung cancer in the neoadjuvant setting
Trial Name
CHECKMATE-816

Primary Outcome(s)

Primary Outcome(s)
co-primary EFS, pCR
Evaluated Outcome
EFS
Form(s)
Form 1

Outcome Data

OS HR
Not mature
DFS Control
EFS 20.8 months, 45.3% at 24 months
DFS Gain
EFS 10.8 months, 18.5% at 24 months
DFS HR
EFS EFS 0.63 (97.38% CI, 0.43-0.91)
pCR Control
2.2%
pCR Gain
21.8%
EFS
20.8 months, 45.3% at 24 months

Final Score (after adjustments)

Final curative score
A
Comment
FDA approval March 2022
Issue date
30.05.2022
Release date
30.05.2022

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response.remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type

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