Trial · NCT06393816
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the 1st-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review. | 12 months | The Progression-Free Rate at 12 months (12M-PFR) will be defined as the percentage of patients with a LCNEC confirmed by centralized expert-pathologist review and presenting a complete response (CR), a partial response (PR) or a stable disease (SD) 12 months after the date of treatment start, as per the independent central radiological review committee |
| Secondary | 12-week Objective Response Rate (ORR) | 12 weeks | proportion of patients with a LCNEC confirmed by centralized expert-pathologist review with a complete response (CR) or partial response (PR), 12 weeks after the date of treatment start |
| Secondary | 12-week Disease Control Rate | 12 weeks | proportion of patients with a LCNEC confirmed by centralized expert-pathologist review with a complete response (CR), partial response (PR) or with stable disease (SD), 12 weeks after the date of treatment start |
| Secondary | Progression-Free Survival (PFS) | From date of the first study treatment administration until the date of first documented radiological progression or date of death from any cause, assessed up to 63 months | time from the date of first study treatment administration to the date of first documented disease progression (reviewed centrally) or the date of death from any cause. Patients without event at the time of analysis will be censored at the date of their last tumor assessment. |
| Secondary | Overall Survival | from the date of first study treatment administration to the date of death from any cause, assessed up to 63 months | time from the date of first study treatment administration to the date of death from any cause. Patients still alive at the time of the analysis will be censored at the time they are known to be alive |
| Secondary | Safety profile : description of treatment-emergent Adverse Events | 27 months and 90 days | All adverse events (AE), all serious adverse events, all immune mediated AE and all Adverse Events of Special Interest will be described using the NCI-CTC version 5.0 |
| Other | Treatment effectiveness of the experimental combination compared to an external control arm | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 63 months | PFS and OS will be compared between experimental arm (durvalumab with platinum-etoposide) and an external control arm from the ESME-AMLC real-world database. This comparison will be performed through combined statistical approach using the emulation of a target trial associated with appropriate statistical adjustment techniques to control for confounding biases and thereby reach causal inference capability. The emulation process will consist of outlining key elements of this target trial protocol and then applying them to the ESME data. |
| Other | Histopathological diagnosis concordance rate | Through central histopathological completion, an average of 6 weeks | The proportion of patients with a histopathological diagnosis confirmed by central review will be described. The proportion of patients with a histopathological diagnosis confirmed by central review will be described. |
| Other | 12-week Objective Response Rate as a predictive and prognostic factors | 12 weeks | The 12W-ORR will be studied as predictive (12M-PFR and ORR) and prognostic factors (OS) of efficacy |
| Other | Overall Survival in the whole study population | From the date of first study treatment administration to the date of death from any cause, assessed up to 63 months | Overall study as usually published in other studies (in which the diagnosis is not confirmed). |
| Other | PD-L1 expression as a predictive and prognostic biomarker | From the date of first study treatment administration to the date of death from any cause, assessed up to 63 months | PD-L1 expression on tumor cells (TCs) and immune cells (ICs), will be studied as predictive (12M-PFR and ORR) and prognostic factors (OS) of efficacy. |
| Other | Retinoblastoma-1-gene (Rb1) mutation as a predictive and prognostic biomarker | From the date of first study treatment administration to the date of death from any cause, assessed up to 63 months | Retinoblastoma-1-gene (Rb1) mutation will be studied as predictive (12M-PFR and ORR) and prognostic factors (OS) of efficacy. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06393816/registered