T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC

Sponsor
The Netherlands Cancer Institute
Study ID
NCT03784599
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Trastuzumab emtansine — DRUG
    Infusion
  • Osimertinib — DRUG
    Tablet

Study Details

This is a single arm open-label multi-center phase II study, investigating disease control rate after 3 months of treatment with trastuzumab-emtansine/osimertinib combination therapy in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with HER2 bypass track resistance.

Key Dates

Start date
Dec 18, 2018
Status verified
Nov 2022
Primary completion
May 17, 2021
Completion
May 17, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab-emtansine and osimertinib
    Trastuzumab-emtansine 3.6 mg/kg, intravenously, every 3 weeks Osimertinib 80 mg once daily, orally, continuous Treatment will be continued until tumor progression (according to RECIST v1.1) confirmed by tumor imaging, unacceptable toxicity, or death occurs.

Primary Outcome Measure

Safety (intensity and incidence of adverse events) [ Time Frame: Up to 30 days after last study drug intake ]

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