3
Indication details
- Combined Agent(s)
- Gemcitabine + cisplatin
- Control Arm
- Placebo + gemcitabine + cisplatin
- FDA Therapeutic Indication
- First-line treatment of recurrent or metastatic nasopharyngeal carcinoma
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Nasopharyngeal carcinoma
- Tumour Stage
- Recurrent or metastatic
- Trial Name
- CAPTAIN-1st
- NCT Number
- NCT03707509
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- Not EMA approved
- Comment
- Approved in China by the National Medical Products Administration
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 6.9 months (prespecified interim analysis)
- PFS Gain
- 3.9 months
- PFS HR
- 0.51 (0.37-0.69)
Adjustments
- QoL Comment
-
QoL not a prespecified endpoint
- Toxicity Comment
-
4% vs 1% treatment-related deaths (p=0.21, not significant)
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
Not EMA or FDA approved.
Approved in China by the National Medical Products Administration.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 353
- Scorecard version
- 1
- Issue date
- 22.09.2022
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.