4
Indication details
- Control Arm
- Platinum based ChT (Crossover allowed)
- Therapeutic Indication
- First-line locally advanced NSCLC who are not candidates for definitive chemoradiation or metastatic NSCLC
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- PD-L1>50% negative EGFR, ALK or ROS1
- Trial Name
- EMPOWER-Lung 1
- NCT Number
- NCT03088540
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2021
- EMA Approval
- EMA (CHMP) May 2021 EC decision July 2021
Primary Outcome(s)
- Primary Outcome(s)
- OS/PFS (74% crossed over)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 14.2 months
- OS Gain
- 10.7 months (Calculated estimate of gain based on PE HR 0.57)
- OS HR
- 0.57 (0.42-0.77)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 254
- Scorecard version
- 1
- Issue date
- 29.03.2021
- Last update
- 16.08.2023
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.