4
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Sub-Group
- ALK+
- Tumour stage
- Metastatic
- Control Arm
- Crizotinib
- Treatment Setting
- Untreated ALK-positive
- Trial Name
- J-ALEX
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 10.2 months
- PFS Gain
- 19.8 months*
- PFS HR
- 0.34 (0.21-0.54)
- Toxicity Comment
- Improved toxicity profile
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Toxicity adjustment
- 1+
- Final non-curative Score
- 4
- Comment
- *Calculated estimate of gain based on PE HR 0.34
- Release date
- 15.05.2019
- Last update
- 02.10.2020
DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression