Trial · NCT07061080
Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
NCT07061080, Phase 2, Terminated, Grupo Espanol de Tumores Neuroendocrinos
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab. Trials, record NCT07061080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07061080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
- NCT number
- NCT07061080
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Conditions
- Advanced Neuroendocrine Carcinomas of The Digestive System, Advanced Neuroendocrine Carcinomas Unknown Primary Origin
- Interventions
- Tarlatamab, standard of care second-line chemotherapy (FOLFIRI)
- First posted
- 2025-07-11
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) rate | Throughout the study period, with an average follow-up of 3 years | The percentage of patients without progression as defined by RECIST V1.1 criteria or death. PFS rate will be calculated for each treatment arm separately once 38 PFS events are reported in the first 54 patients included (27 per treatment arm). Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment. |
| Primary | Overall Survival (OS) rate at 12-months | Throughout the study period, at 12 months from the start of treatment | Defined as the percentage of patients alive after 12 months from the first dose of study treatment. OS will consider death from any cause as an event. Patients alive and free of events at the date of the analysis will be censored at their last known contact. OS will be calculated for each treatment arm separately. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patient status at each visit according to protocol. Long term follow up to be performed at least every 6 months |
| Secondary | Objective response rate (ORR) | Throughout the study period, with an average follow-up of 3 years | Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST 1.1. This will be considered as the percentage/proportion of patients with complete response (CR) or partial response (PR) as their overall best response throughout the study period. Objective responses will be assessed locally by the investigator according to RECIST, version 1, and indicating the change in size of tumors as compared with baseline, at the first dose of study treatment. |
| Secondary | Disease control rate (DCR) | Throughout the study period, with an average follow-up of 3 years | Assessed locally by the investigator through imaging follow-up (CT scan/MRI) using RECIST 1.1. DCR will include the percentage/proportion of patients with CR, PR, or SD (maintained \> 4 months) as their overall best response throughout the study period. The DCR will be estimated by binomial proportion, dividing the number of patients with CR, PR or SD for at least 4 months for DCR by the total number of patients studied in the population. The corresponding exact 2-sided 95% CIs will be provided. Changes in tumor size from baseline will be calculated and displayed graphically, where appropriate |
| Secondary | Duration of response (DoR) | Throughout the study period, with an average follow-up of 3 years | Time from first response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment. DoR will be summarized using Kaplan-Meier method and displayed graphically, where appropriate. The mean, median DoR and 95% CIs will be provided. |
| Secondary | Patient reported health-related quality of life (HRQoL) | Throughout the study period, with an average follow-up of 3 years | Assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), version 3. Summary statistics \[mean (and SE), median, range and 95% CI\] of absolute scores will be reported for all of the subscales of the EORTC QLQ-C30 questionnaire. The mean change of absolute scores from baseline (and 95% CI) will also be assessed. Line charts depicting the means and mean changes of items and subscales over time will be provided. The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It consists of 15 scales, including 5 functional scales, 3 symptom scales, and 9 multi-item and single-item scales for measuring symptoms and global health status. Scores range from 0 to 100, with higher scores indicating better functioning or higher quality of life for functional scales and global health status, but higher scores indicate a higher level of symptoms for symptom scales |
| Secondary | Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) | Throughout the study period, with an average follow-up of 3 years | Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07061080
GET https://conductscience.org/api/trials/v1/NCT07061080/registered