Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Entrectinib

STARTRK-1; STARTRK-2; ALKA-372-001
Back

3

Indication details

Control Arm
Single arm
Therapeutic Indication
Treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Stage
Advanced
Tumour Sub-Group
Refractory NTRK fusion–positive cancers
Trial Name
STARTRK-1; STARTRK-2; ALKA-372-001
NCT Number
NCT02097810 │ NCT02568267
Trial Phase
Phase I/II

Approval details

FDA Approval
FDA approval August 2019
EMA Approval
EMA (May 2020) EC decision July 2020

Primary Outcome(s)

Primary Outcome(s)
ORR, DOR
Evaluated Outcome
ORR, DOR
Form(s)
Form 3

Outcome Data

PFS Control
15.7 months
ORR
67.1%
DoR
15.7 months

Adjustments

QoL Comment
QoL data pending

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
210
Scorecard version
1
Issue date
23.07.2020
Last update
16.08.2023
Entrectinib STARTRK-1; STARTRK-2; ALKA-372-001

PRELIMINARY SCORE

ORR

ADJUSTMENTS

?
QoL data pending
Entrectinib STARTRK-1; STARTRK-2; ALKA-372-001

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
3
Overall Response Rate / Duration of Response
Thoracic Malignancies
Treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors
Entrectinib
Single arm

My watchlist

    pdf
    pptx

    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.

    This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

    For more detailed information on the cookies we use, please check our Privacy Policy.

    Customise settings
    • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.