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3
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
Advanced
Control Arm
Single arm study
Treatment Setting
Treatment of adult patients previously treated with an ALK inhibitor. 222 patients enrolled: 112 patients 90mg vs 110 patients 180mg

Primary Outcome(s)

Primary Outcome(s)
ORR (Phase II) 180 mg
Form(s)
Form 3

Outcome Data

PFS Control
12.9 months
PFS Gain
12 months
ORR
54% achieved in ORR
DoR
11.1 months
Toxicity Comment
Tolerable toxicity

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Issue date
16.03.2020
Release date
16.03.2020

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; mDoR, median duration of response; mPFS, median progression-free survival; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate

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