2
Indication details
- Combined Agent(s)
- Platinum + etoposide (carboplatin or cisplatin)
- Control Arm
- Placebo + platinum + etoposide (carboplatin or cisplatin)
- Therapeutic Indication
- Tislelizumab, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Small-cell lung cancer
- Trial Name
- RATIONALE 312
- NCT Number
- NCT04005716
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) March 2025. Pending EC decision.
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.3 months
- PFS Gain
- 0.4 months
- PFS HR
- 0.64 (0.52-0.78)
- OS Control
- 13.5 months
- OS Gain
- 2 months
- OS HR
- 0.75 (0.61-0.93)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 491
- Scorecard version
- 1
- Issue date
- 31.03.2025
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.