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