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DISEASE & TREATMENT SETTING

KEYTRUDA QLEX: unresectable metastatic gastric cancer with HER2 positive, PD-L1 stated without a specific alteration (first-line)

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

1.8 Gastric Cancer KEYTRUDA QLEX, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .

Broader topic: Gastric Cancer

Source population
Not part of this definition
Disease extent
metastatic
Treatment line
first-line
Stage
Not part of this definition
Resectability
unresectable
Biomarkers, prior therapy and derivation
molecular
  1. gene
    HER2
    alteration
    positive
    status
    present
  2. gene
    PD-L1
    alteration
    stated without a specific alteration
    status
    present
prior therapy
    derivation status
    source-attested
    derivation note
    Scoped from the FDA approved indication for KEYTRUDA QLEX (product label). Only dimensions stated in that wording are part of this definition.
    source wording
    1.8 Gastric Cancer KEYTRUDA QLEX, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .

    Study evidence for this setting

    6 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

    NCT01041404 · Source cited / selected · Scope: unclear

    ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

    6 outcome links · 2 safety-group records · 2 quality-of-life measures

    →

    NCT02983045 · Registry condition search · Scope: unclear

    A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors

    3 outcome links · 10 safety-group records · 0 quality-of-life measures

    →

    NCT03154190 · Registry condition search · Scope: unclear

    Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →

    NCT03615326 · Source cited / selected · Scope: unclear

    Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarci

    6 outcome links · 5 safety-group records · 0 quality-of-life measures

    →

    NCT03675737 · Source cited / selected · Scope: unclear

    Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

    6 outcome links · 3 safety-group records · 0 quality-of-life measures

    →

    NCT05091528 · Registry condition search · Scope: unclear

    A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →
    Source relationships and population-mapping limitations
    bindings
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice