Trial · NCT07016230
Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB)
NCT07016230, Phase 2, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB). Trials, record NCT07016230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07016230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB)
- NCT number
- NCT07016230
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Conditions
- Metastatic/Locally Advanced Small-Cell Lung Cancer, Metastatic/Locally Advanced Poorly Differentiated NEC
- Interventions
- Tarlatamab
- First posted
- 2025-06-11
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To estimate the objective response rate (ORR) | Within the 4 months of treatment initiation | |
| Secondary | Objective response rate at different timepoints (ORR) | up to 18 months | |
| Secondary | Duration of response (DOR) | From cycle 3 (Week 6; each cycle is 28 days) up to 2 years after the EoT, an average of 26 months | defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause. Duration of response will be measured for responding patients (CR or PR) only |
| Secondary | Clinical benefit rate (CBR) | During treatment period, a median of 4 months | defined as the presence of at least a PR or CR, or a stable disease (SD) \>6 months |
| Secondary | Progression free survival (PFS) | From the time date of the first dose until progression or death from any cause, whichever occurs first, assessed up to 18 months | defined as the time from date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, follow-up will be censored at the date of last radiological assessment without progression, unless death occurs within 12 weeks following the date of last known progression-free, in which case the death will be counted as a PFS event |
| Secondary | Frequency of all adverse events | From enrollment until 24 months of EoT | |
| Secondary | Severity of all adverse events | From enrollment until 24 months of EoT | As defined by the NCI-CTCAE v5.0. |
| Secondary | frequency of CRS and ICANS | From enrollment until 24 months of EoT | graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria |
| Secondary | severity of CRS and ICANS | From enrollment until 24 months of EoT | graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria |
| Secondary | Proportion of treatment discontinuation due to any AEs | Treatment Period, median of 4 months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
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/NCT07016230
GET https://conductscience.org/api/trials/v1/NCT07016230/registered