4
Indication details
- Control Arm
- Pemetrexed + cisplatin or carboplatin
- Therapeutic Indication
- First-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- ALK+
- Trial Name
- PROFILE 1014
- NCT Number
- NCT01154140
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved
- EMA Approval
- EMA (CHMP) October 2015 EC decision December 2015
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)
- OS Control
- 47.5 months
- OS Gain
- 15 months (calculated estimate of gain based on PE HR 0.76)
- OS HR
- 0.76 (0.548-1.053) Not significant
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 64
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 17.08.2023
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.