5
Indication details
- Control Arm
- Docetaxel
- Therapeutic Indication
- As monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Squamous or non-squamous non-small-cell lung cancer
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- OAK
- NCT Number
- NCT02008227
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2016
- EMA Approval
- EMA (CHMP) July 2017 EC decision September 2017
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS ITT (n=850)
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 9.6 months
- OS Gain
- 4.2 months
- OS HR
- 0.75 (0.64-0.89)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
Improved toxicity profile
Score (after adjustments)
- Preliminary non-curative score
-
4
- Toxicity adjustment
- 1+
- Non-curative score
-
5
- Comment
-
In the secondary efficacy population with increased sample size (n=1225) the final ESMO-MCBS score is 3: HR 0.78 95%CI: 0.68–0.89, median control 9.8, median gain 3.5, preliminary grade 2 with a toxicity up grade of 1 point (Maziers et al, JTO 2021)
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 126
- Scorecard version
- 1
- Issue date
- 15.05.2019
- Last update
- 17.08.2023
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.