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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
Pemetrexed + cisplatin or carboplatin
Treatment Setting
1st line stage III or IV non-squamous, with ALK mutation
Trial Name
PROFILE 1014

Primary Outcome(s)

Primary Outcome(s)
PFS (crossover allowed)
Form(s)
Form 2b

Outcome Data

PFS Control
7.0 months
PFS Gain
3.9 months
PFS HR
0.45 (0.35-0.60)
QoL Comment
Improved

Final Score (after adjustments)

Preliminary non-curative score
3
QoL adjustment
1+
Final non-curative Score
4

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; 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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