Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
Phase 3 – large-scale trial before approval
Conditions:
Non-small cell lung cancer
Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
trial.available_in:
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Overview
Trial status: Authorised
OS, defined as the time from randomization until death from any cause, Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Description
OS, defined as the time from randomization until death from any cause, Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 93 participants
Interventions
OPDIVO 10 mg/mL concentrate for solution for infusion.
Drug
IMFINZI 50 mg/mL concentrate for solution for infusion.
Drug
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Drug
BI 1810631
Drug
Tecentriq 1 200 mg concentrate for solution for infusion
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