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2

Indication details

Control Arm
Erlotinib
Therapeutic Indication
As monotherapy for the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based ChT
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer - Squamous cell
Tumour Stage
Locally advanced or metastatic
Trial Name
LUX - Lung 8
NCT Number
NCT01523587
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval April 2016
EMA Approval
EMA (CHMP) February 2016 EC decision April 2016

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
6.8 months
OS Gain
1.0 months
OS HR
0.84 (0.73-0.97)

Adjustments

QoL Comment
Improved overall health-related QoL
Toxicity Comment
Similar toxicity profile

Score (after adjustments)

Preliminary non-curative score

1

QoL adjustment
1+
Non-curative score

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
70
Scorecard version
1
Issue date
11.12.2018
Last update
16.08.2023
Afatinib LUX - Lung 8

PRELIMINARY SCORE

OS

ADJUSTMENTS

Improved QoL
Afatinib LUX - Lung 8

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
2
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Thoracic Malignancies
As monotherapy for the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based ChT
Afatinib
Erlotinib

My watchlist

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    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.

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