Trial · NCT05740566
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
NCT05740566, Phase 3, Active not recruiting, Amgen; results first posted 2026-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer. Trials, record NCT05740566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05740566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
- NCT number
- NCT05740566
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Small Cell Lung Cancer (SCLC)
- Interventions
- Tarlatamab, Lurbinectedin, Topotecan, Amrubicin
- First posted
- 2023-02-23
- Last updated
- 2026-01-05
- Results first posted
- 2026-01-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months | OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 4 years | PFS was defined as time from randomization until disease progression (PD) or death from any cause, whichever occurs first for all participants. Progression was based on investigator assessment of disease response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: radiologic detection of ≥ 20% increase in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Up to approximately 4 years | The EORTC QLQ-C30 was developed to assess quality of life in cancer participants across tumor types. It was a self-reported, 30-item generic instrument that assessed five functional scales (physical, role, emotional, cognitive, social); nine disease symptom items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties); and a global health status (GHS)/quality of life (QOL) scale. Questionnaire score ranged from 0 to 100. For the functional scales, higher scores indicated high/healthy level of functioning; for the disease symptom scales, higher scores indicated greater symptom burden; and for the GHS/QoL scale, higher scores represented a high QoL. A negative change from baseline indicated reduction in functioning, improvement in symptom burden and reduction in health and quality of life. |
| Secondary | Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13) | Up to approximately 4 years | The EORTC QLQ-LC13 was a disease-specific supplement to the EORTC QLQ-C30. It included multi-item and single-item measures of lung cancer symptoms (coughing, hemoptysis, dyspnea, pain) and treatment side effects (hair loss, neuropathy, sore mouth, dysphagia). Scores ranged from 0 to 100, with higher scores indicating a greater degree of symptom severity. A negative change from baseline indicated improvement in symptom burden or side effect severity. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 4 years | ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to \< 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 4 years | DCR was defined as the percentage of participants documented to have a CR, PR or stable disease (SD) per RECIST v1.1. CR: complete disappearance of all lesions and pathologic lymph nodes reduced in short axis to \< 10 mm. PR: decrease in tumor burden of ≥ 30% relative to baseline, or complete disappearance of all index lesions with the presence of non-index lesions. SD: Index lesions not meeting the criteria for CR, PR, or PD or the persistence of one or more non-index lesions. Exact 95% CIs were calculated using the Clopper-Pearson method. |
| Secondary | Duration of Response (DOR) | Up to approximately 4 years | DOR was defined as the time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first determined by the investigator per RECIST v1.1. Only participants who had achieved OR will be evaluated for DOR. PD: radiologic detection of ≥ 20% increase in in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. |
| Secondary | PFS at Year 1 | 1 year | PFS was defined as time from randomization until PD or death from any cause, whichever occurs first for all participants. Progression was based on investigator assessment of disease response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: radiologic detection of ≥ 20% increase in in the sum of diameters of target lesions and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | OS at Year 1, 2 and 3 | 1 year, 2 years and 3 years | OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Number of Participants With Anti-tarlatamab Antibodies | Up to approximately 4 years | Incidence of treatment emergent adverse events including grade ≥ 3 treatment emergent adverse events, serious treatment emergent adverse events, treatment emergent adverse events leading to treatment discontinuation, fatal treatment emergent adverse events, and treatment-related treatment emergent adverse events. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 4 years | |||
| SECONDARY | Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Up to approximately 4 years | |||
| SECONDARY | Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13) | Up to approximately 4 years | |||
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 4 years | |||
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 4 years | |||
| SECONDARY | Duration of Response (DOR) | Up to approximately 4 years | |||
| SECONDARY | PFS at Year 1 | 1 year | |||
| SECONDARY | OS at Year 1, 2 and 3 | 1 year, 2 years and 3 years | |||
| SECONDARY | Number of Participants With Anti-tarlatamab Antibodies | Up to approximately 4 years | |||
| SECONDARY | Trough Concentration (Ctrough) of Tarlatamab | Up to 1 year |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Standard of Care (SOC) | 8.3 | 95% Confidence Interval 7.0 to 10.2 | months | |
| Overall Survival (OS) | Tarlatamab 1 mg to 10 mg Q2W | 13.6 | 95% Confidence Interval 11.1 to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care (SOC) | 255 | |
| Overall Study | STARTED | Tarlatamab 1 mg to 10 mg Q2W | 254 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 0 | |
| Overall Study | COMPLETED | Tarlatamab 1 mg to 10 mg Q2W | 0 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) | 255 | |
| Overall Study | NOT COMPLETED | Tarlatamab 1 mg to 10 mg Q2W | 254 |
Source ClinicalTrials.gov
Adverse events384
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 155 | 244 | |
| other | Anaemia | Blood and lymphatic system disorders | Tarlatamab 1 mg to 10 mg Q2W | 77 | 252 | |
| other | Leukopenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 54 | 244 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tarlatamab 1 mg to 10 mg Q2W | 24 | 252 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 10 | 244 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tarlatamab 1 mg to 10 mg Q2W | 23 | 252 | |
| other | Neutropenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 73 | 244 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tarlatamab 1 mg to 10 mg Q2W | 27 | 252 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 60 | 244 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tarlatamab 1 mg to 10 mg Q2W | 14 | 252 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care (SOC) | 152 | 255 |
| Total, all-cause mortality | Tarlatamab 1 mg to 10 mg Q2W | 111 | 254 |
| Total, other adverse events | Standard of Care (SOC) | 234 | 244 |
| Total, other adverse events | Tarlatamab 1 mg to 10 mg Q2W | 244 | 252 |
| Total, serious adverse events | Standard of Care (SOC) | 125 | 244 |
| Total, serious adverse events | Tarlatamab 1 mg to 10 mg Q2W | 129 | 252 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tarlatamab 1 mg to 10 mg Q2W vs Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Tarlatamab 1 mg to 10 mg Q2W vs Standard of Care (SOC): serious adverse events | Trial comparisons |
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/NCT05740566
GET https://conductscience.org/api/trials/v1/NCT05740566/events?page=2