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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


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