5
Indication details
- Control Arm
- Cisplatin + pemetrexed
- FDA Therapeutic Indication
- As monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s) - Del19/L858R pre-planned subgroup analysis
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- EGFR+
- Trial Name
- LUX - Lung 3
- NCT Number
- NCT00949650
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval July 2013
- EMA Approval
- EMA (CHMP) July 2013 EC decision September 2013
- Comment
- FDA and EMA labels do not state del19/L858R but included as a pre-planned and clinically relevant subgroup
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 6.9 months
- PFS Gain
- 6.7 months
- PFS HR
- 0.47 (0.34-0.65)
- OS Control
- 21.1 months
- OS Gain
- 12.2 months
- OS HR
- 0.54 (0.36-0.79)
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 61
- Scorecard version
- 1
- Issue date
- 11.12.2018
- 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.