4
Indication details
- Control Arm
- Single arm
- Therapeutic Indication
- Treatment for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Small-cell lung cancer
- Trial Name
- ADRIATIC
- NCT Number
- NCT03703297
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2024
- EMA Approval
- EMA (CHMP) positive recommendations on new therapeutic indications, January 2025. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 9.2 months
- PFS Gain
- 7.4 months
- PFS HR
- 0.76 (97.195% CI, 0.59-0.98 / 95% CI: 0.61–0.95) P=0.02 < 0.02805 (significance level at interim after alpha recycling for OS)
- OS Control
- 33.4 months. 47.6% at 36 months
- OS Gain
- 22.5 months. 8.9% gain at 36 months
- OS HR
- 0.73 (98.321% CI, 0.54-0.98 / 95% CI: 0.57-0.93) P=0.01 < 0.01679 (significance level at interim)
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
- 483
- Scorecard version
- 1
- Issue date
- 18.12.2024
- Last update
- 31.01.2025
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.