A
Indication details
- Control Arm
- Platinum-Based ChT
- Therapeutic Indication
- Alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Sub-Group
- ALK positive
- Trial Name
- ALINA
- NCT Number
- NCT03456076
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval April 2024
- EMA Approval
- EMA (CHMP) April 2024. Pending EC decision (recommendations on extensions)
- Comment
- FDA approval for ITT
Primary Outcome(s)
- Primary Outcome(s)
- DFS (investigator assessment)
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- Immature
- DFS Control
- 41.3 months: 63.7% (intention-to-treat population)
- DFS Gain
- NR
- DFS HR
- 0.24 (95% CI, 0.13-0.43) (intention-to-treat population)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Final Score (after adjustments)
- Final curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 439
- Scorecard version
- 1
- Issue date
- 27.05.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.