A
Indication details
- Combined Agent(s)
- Platinum-based chemotherapy
- Control Arm
- Placebo with platinum-based chemotherapy
- FDA Therapeutic Indication
- 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
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, 12 month EFS 64.5%
- EFS gain
- Estimated EFS gain =12.2 months, 12 month EFS gain 8.9%
- 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 in Durvalumab arm
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
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.