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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+
Control Arm
Single arm study
Treatment Setting
139 patients had received ≥1 generation ALK TKI (EXP3B to EXP5)

Primary Outcome(s)

Primary Outcome(s)
ORR, DoR, PFS Phase I/II
Form(s)
Form 3

Outcome Data

ORR
40% achieved in ORR (95% CI 32%–49%), mPFS, 6.9 months (95% CI 5.4–8.2)
DoR
7.1 months (95% CI 5.6–24.4)

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Issue date
04.12.2019
Release date
04.12.2019

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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