3
Indication details
- Control Arm
- Single arm
- FDA Therapeutic Indication
- For adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- METex14 skipping
- Trial Name
- VISION
- NCT Number
- NCT02864992
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA accelerated approval February 2021. FDA approval February 2024
- EMA Approval
- EMA (CHMP) December 2021 EC decision February 2022
Primary Outcome(s)
- Primary Outcome(s)
- ORR and DoR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 11.2 months
- OS Control
- 19.6 months
- ORR
- 51.4 (45.8-57.1) cohorts A and C
- DoR
- 18.0 (12.4-46.4) cohorts A and C
Adjustments
- QoL Comment
-
QoL as secondary endpoint
- Toxicity Comment
-
Treatment-related AEs occurring in ≥10%, Grade ≥3: Peripheral edema
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 253
- Scorecard version
- 1
- Issue date
- 29.03.2021
- Last update
- 22.03.2024
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.