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