Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT05298176
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Afatinib, Osimertinib, Carboplatin and Pemetrexed — DRUG
    This study consists of 2 parts. Part 1 is defined as a first line treatment with afatinib orally (30 mg once a day) for the first 6 weeks, followed by concurrent use of afatinib (20mg once a day, part 1B) plus 2 cycles of carboplatin and pemetrexed (21 days per cycle); followed by afatinib monotherapy (30mg once a day). Part 2 comprises a 2nd line treatment with osimertinib (80 mg once daily) after failure of part 1, only in T790M positive patients for the first 6 weeks, followed by concurrent use of osimertinib (80mg once a day) plus 2 cycles of carboplatin and pemetrexed (21 days per cycle); followed by osimertinib monotherapy (80mg once a day).

Study Details

The aim of the COMBINATION trial is to prospectively study the sequential approach of using afatinib combined with a short course of chemotherapy, followed by osimertinib, upon progression and acquisition of a T790M mutation, also combined with a short course of chemotherapy.

Key Dates

Start date
Jan 4, 2022
Status verified
Mar 2025
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024

Study Design

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

Arms

  • Experimental: Patients with untreated EGFR positive NSCLC tumors
    TKI-naïve advanced NSCLC patients, harboring a non-exon20insertion uncommon EGFR mutation, who are eligible for treatment with afatinib in 1st line

Primary Outcome Measure

Disease control rate (DCR) [ Time Frame: 18 months ]

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