EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Sponsor
Region Skane
Study ID
NCT06486142
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afatinib/Dacomitinib — DRUG
    Second-generation EGFR-inhibitors
  • Osimertinib — DRUG
    Third-generation EGFR-inhibitor

Study Details

The purpose of this study is to evaluate the optimal sequence of EGFR-inhibitors in lung cancer patients with EGFR-positive tumors not amenable for curative treatment. Life quality, adverse effects and tumor response will be evaluated and analyses of obtained blood and tumor samples will be performed to identify molecular profiles and biomarkers that can be used for treatment decisions.

Key Dates

Start date
Sep 21, 2022
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Afatinib/Dacomitinib
  • Active Comparator: Osimertinib

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Maximum 6 years ]

Central Contacts

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