4
Indication details
- Combined Agent(s)
- Cisplatin
- Control Arm
- Cisplatin + gemcitabine
- FDA Therapeutic Indication
- In combination with cisplatin for the first-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- NCT Number
- NCT00087711
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved
- EMA Approval
- EMA (CHMP) May 2009 EC decision July 2009
Primary Outcome(s)
- Primary Outcome(s)
- OS (non-inferiority)
- Evaluated Outcome
- OS (NI)
- Form(s)
- Form 2c
Outcome Data
- OS Control
- 10.4 months
- OS Gain
- 1.4 months
- OS HR
- 0.81 (0.70-0.94)
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
Less grade 3+ toxicity: neutropenia anaemia thrombocytopenia
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 66
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 18.08.2023
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.