Trial · NCT07561645
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 | Overall Survival (OS) | app. 69 months | To assess the efficacy of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival. |
| Secondary | Objective Response Rate (ORR) | app. 69 months | defined as PR or CR according to RECIST v1.1 as assessed by local investigator |
| Secondary | Progression-Free Survival (PFS) | app. 69 months | defined as time from first application of obrixtamig to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first |
| Secondary | Duration Of Response (DOR) | app. 69 months | defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first |
| Secondary | Disease Control Rate (DCR) | app. 69 months | defined as combination of CR, PR and SD according to RECIST v1.1 |
| Secondary | immune Objective Response Rate (iORR) | app. 69 months | immune ORR (iORR) defined as iPR or iCR according to iRECIST |
| Secondary | immune Progression Free Survival (iPFS) | appr. 69 months | defined as time from first application of obrixtamig to progression according to iRECIST, clinical progression with change of treatment or death from any cause, whichever occurs first |
| Other | PFS, OS, DOR and ORR in central pathology confirmed cases of LCNEC | app. 69 months | |
| Other | PFS, OS, DOR and ORR in defined LCNEC molecular subtypes | appr. 69 months | (type I, type II - NSCLC and SCLC like) and depending on DLL3 expression to identify potential correlation between responses in molecular subtypes and DLL3 expression levels (high vs. low) |
| Other | Quality of Life assessment | appr. 69 months | Changes from baseline in EORTC-QLQ-C30 as well as QLQ-LC13 global and LC specific health/QoL score. |
| Other | further exploratory end points | appr. 69 months | For other exploratory end points respective biomaterials will be banked within the trial but analyses will be contingent on specimen availability. These analyses will include but are not limited to: * Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response * Mutational landscape of LCNEC in comparison to SCLC as well as squamous and adenocarcinoma of the lung * Dynamics of circulating tumor DNA levels (changes from baseline) * Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression) * Expression of DLL3 in pre- and post-treatment samples including analyses in BI-designated central lab * Composition of the tumor microenvironment using multiplex immunofluorescence |
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/NCT07561645/registered