3
Indication details
- Control Arm
- Crizotinib
- Therapeutic Indication
- Ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell lung cancer
- Tumour Stage
- Advanced or metastatic
- Tumour Sub-Group
- ALK+
- Trial Name
- eXALT3
- NCT Number
- NCT02767804
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS (ITT). OS as secondary endpoint.
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 12.7 months
- PFS Gain
- 13.1 months
- PFS HR
- 0.51 (95%CI, 0.35-0.72) P < .001
- OS HR
- Immature (crossover allowed, outside the protocol)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 484
- Scorecard version
- 1
- Issue date
- 29.01.2025
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.