A
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- EGFR exon 19 deletions or exon 21 (L858R) mutation
- Trial Name
- ADAURA
- NCT Number
- NCT02511106
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2020
- EMA Approval
- EMA CHMP April 2021 EC decision July 2021
- Comment
- EMA approval was based on all patients, including those with stage Ib disease, and so data shown are for all patients
Primary Outcome(s)
- Primary Outcome(s)
- DFS
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 5-year 78%
- OS Gain
- 5-year 10%
- OS HR
- 0.49 (95.03%CI 0.34-0.70)
- DFS Control
- 4-year 38%
- DFS Gain
- 4-year 35%
- DFS HR
- 0.27 (95.03%CI 0.21-0.34)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 241
- Scorecard version
- 1
- Issue date
- 01.03.2021
- Last update
- 15.11.2023
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.