4
Indication details
- Combined Agent(s)
- Standard systemic therapy (investigator’s choice of immune checkpoint inhibitor [nivolumab, pembrolizumab, or atezolizumab] or docetaxel)
- Control Arm
- Standard therapy alone
- FDA Therapeutic Indication
- Addition of tumor-treating fields (TTFields) to standard-of-care (SOC) therapies in patients with non–small cell lung cancer (NSCLC) after disease progression on or following platinum-based treatment
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Metastatic
- Trial Name
- LUNAR
- NCT Number
- NCT02973789
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Premarket approval January 2024
- Comment
- Premarket approval (PMA), January 2024. Under substantive review by the FDA. Novocure expects to receive a regulatory decision from FDA in second half 2024.
Primary Outcome(s)
- Primary Outcome(s)
- OS (ITT)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.1 months
- PFS Gain
- 0.7 months
- PFS HR
- 0.85 (0.67-1.11)
- OS Control
- 9.9 months
- OS Gain
- 3.3 months
- OS HR
- 0.74 (0.56-0.98)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 476
- Scorecard version
- 1
- Issue date
- 27.11.2024
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.