A
Indication details
- Combined Agent(s)
- Platinum-containing ChT
- Control Arm
- Placebo + platinum-containing ChT
- Therapeutic Indication
- Pembrolizumab with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC)
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Early stage resectable neoadjuvant
- Trial Name
- KEYNOTE-671
- NCT Number
- NCT03425643
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2023
- EMA Approval
- EMA (CHMP) February 2024. EC decision April 2024.
Primary Outcome(s)
- Primary Outcome(s)
- EFS, OS
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 3-year OS: 64%
- OS Gain
- 3-year OS: 7%
- OS HR
- 0.72 (0.56-0.93)
- EFS control
- 18.3 months - 3-year 35%
- EFS gain
- 28.9 months estimated - 3-year 19%
- EFS HR
- 0.59 (0.48-0.72)
Adjustments
- QoL Comment
-
No QoL Benefit
- Toxicity Comment
-
>10% discontinued due to AEs
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 402
- Scorecard version
- 1
- Issue date
- 20.11.2023
- Last update
- 30.01.2025
Legend
Information about symbols, abbrevations and color codes
- 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
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: