3
Indication details
- Combined Agent(s)
- Carboplatin + nab-paclitaxel (Arm B)
- Control Arm
- Paclitaxel + Carboplatin (Arm C)
- Therapeutic Indication
- Tislelizumab in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer - Squamous cell
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- RATIONALE 307
- NCT Number
- NCT03594747
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) May 2024. EC decision July 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint (crossover allowed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.5 months
- PFS Gain
- 4.1 months
- PFS HR
- 0.43 (0.31-0.60)
- OS Control
- 19.4 months
- OS Gain
- 3.9 months
- OS HR
- 0.84 (0.61-1.14)
Adjustments
- Annotation
- Mature OS NS, but crossover allowed (subsequent immunotherapy had been received by 63.6% patients in arm C), therefore no downgrade applied despite lack of QoL benefit
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
>10% differential in discontinuation due to AE
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 450
- Scorecard version
- 1
- Issue date
- 24.07.2024
- Last update
- 07.11.2024
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.