A
Indication details
- Combined Agent(s)
- Platinum-based chemotherapy
- Control Arm
- Placebo with platinum-based chemotherapy
- Therapeutic Indication
- EMA: Durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.. FDA: Durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumours ≥4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Resectable
- Trial Name
- AEGEAN
- NCT Number
- NCT03800134
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2024
- EMA Approval
- EMA (CHMP) February 2025. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- EFS and pathological complete response (pCR) in ITT. OS as secondary endpoint
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- Immature
- EFS control
- EFS median: 25.9 months
- EFS gain
- Estimated EFS gain: 12.2 months
- EFS HR
- EFS HR (95% CI): 0.68 (0.53-0.88). P= 0.004 for the first interim analysis (31.9% data maturity)
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
12% discontinuation due to AEs
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 465
- Scorecard version
- 1
- Issue date
- 09.10.2024
- Last update
- 28.02.2025
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.