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

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

January 4, 2022

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2024

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Afatinib, Osimertinib, Carboplatin and Pemetrexed

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).

Trial Locations (1)

1081 HV

Amsterdam UMC, location VUmc, Amsterdam

All Listed Sponsors
lead

Amsterdam UMC, location VUmc

OTHER

NCT05298176 - Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors | Biotech Hunter | Biotech Hunter