Trial · NCT06464068
AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA
NCT06464068, Phase 2, Recruiting, Gruppo Oncologico Italiano di Ricerca Clinica
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA. Trials, record NCT06464068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06464068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA
- NCT number
- NCT06464068
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Conditions
- Extrapulmonary Small Cell Carcinoma
- Interventions
- Durvalumab
- First posted
- 2024-06-18
- Last updated
- 2024-06-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | progression free survival (PFS) | 12 months | To evaluate the preliminary efficacy in terms of 12 months progression free survival (PFS) of durvalumab in association with carboplatin or cisplatin and etoposide in first line patients affected by extensive stage EPSCC. PFS isdefined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. According to the results of the CASPIAN trial \[18\] in which was observed a 12-month progression-free survival rates of 5% (2.4-8.0) for patients that had received Platinum-etoposide, it is expected to detect an increasing of at least 10 percentage points (to 15%). |
| Secondary | Objective Response Rate (ORR) | 12 months | Activity of durvalumab in combination with carboplatin or cisplatin plus etoposide in patients with untreated extensive- stage extrapulmonary small cell lung cancer (EPSCC). Activity will be measured as Objective Response Rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1. |
| Secondary | Disease control rate (DCR) | 12 months | Disease control rate (DCR) measured as the percentage of patientswho have archived CR, PR, and stable disease (SD). |
| Secondary | Overall survival (OS) | 24 months | Overall survival (OS), defined as the time from initiation of study treatment to death from any cause. |
| Secondary | Duration of response (DOR) | 12 months | Duration of response (DOR), is defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1. |
| Secondary | quality of life (QoL) | 24 months | To describe change in quality of life of patients during the study, measured as pre-defined PRO endpoints in this study are mean change from baseline in questionnaire administred at the enrollment time (baseline) and after the induction phase (3 +/- 2 weeks) |
| Secondary | incidence, nature, frequency, and severity of Adverse Events (AEs) | 24 months | Safety profile of durvalumab, defined in terms of incidence, nature, frequency, and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0; |
| Other | biomarkers associated with sensitivity/resistance to immune checkpoint inhibitors | 24 months | To identify possible biomarkers associated with sensitivity/resistance to immune checkpoint inhibitors, tumor samples from enrolled patients will undergo whole exome sequencing (WES) and gene expression profiling by using a 3' RNA Seq approach. For all the patients enrolled to investigate the occurrence of genetic alterations that might be associated with acquired resistance to immune checkpoint inhibitors, blood samples will be collected by analyzing the circulating free DNA (cfDNA). To this end, plasma will be collected at baseline, prior to cycle 5, and at the end of treatment (progression of disease). The cfDNA will be analyzed by targeted sequencing panels. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41225446 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06464068
GET https://conductscience.org/api/trials/v1/NCT06464068/registered