Trial · NCT07486817
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment | up to 6 weeks | |
| Secondary | Occurrence of serious adverse events (SAE) during the on-treatment period | up to 1.5 years | |
| Secondary | Occurrence of dose reduction of zongertinib | up to 1.5 years | |
| Secondary | Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs during the on-treatment period | up to 1.5 years | |
| Secondary | Occurrence of Grade ≥3 non-hematological AE during the on-treatment period | up to 1.5 years | |
| Secondary | Occurrence of combination limiting toxicities (CLTs) during the on-treatment period | up to 1.5 years | Specific adverse events (AEs) are classified as combination limiting toxicities (CLTs) in the study protocol, e.g.: * laboratory parameters that exceed predefined limits as defined in the study protocol \* * Treatment-related death (other than death related to progressive disease) * Any AE which causes an interruption or delay to treatment with zongertinib of greater than 7 days * Any AE that requires treatment discontinuation of zongertinib in accordance with the study protocol |
| Secondary | Objective response (OR) according to Response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the investigator | up to 1.5 years | OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) from date of randomization until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent |
| Secondary | Time to OR, defined as the time from date of randomization to first documented confirmed CR or PR among patients with OR as determined by investigator assessment per RECIST 1.1 | up to 1.5 years | |
| Secondary | Duration of OR (DoR), defined as the time from first documented confirmed CR or PR until disease progression or death among patients with OR as determined by investigator assessment per RECIST 1.1 | up to 1.5 years | |
| Secondary | Progression-free survival (PFS), defined as the time from randomization until tumor progression according to RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs earlier | up to 1.5 years | |
| Secondary | Time on treatment (ToT), defined as the time from first dose of study treatment until zongertinib treatment discontinuation or death | up to 1.5 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07486817/registered