Early non-small cell lung cancer
Conditions
Interventions
Drug: Zongertinib
Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Durvalumab
Drug: Nivolumab
Sponsors
Ogawa Shintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2 Patients must be more than 18 years old or over the legal age of consent in their country 3 Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC etc...
Exclusion criteria
Exclusion criteria: 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56) 2. Presence of any co-occurring actionable mutation for which there is an approved targeted therapy in the adjuvant/neoadjuvant setting (e.g. EGFR or ALK). Patients with non-activating EGFR mutations can be considered eligible 3. Incomplete or aborted surgical resection (R1 or greater) etc...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause - Occurrence of trial-related Adverse Events (AEs) more than Grade 3 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 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Romania, South Korea, Spain, Sweden, Taiwan, Turkey, United States of America
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed