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