Trial · NCT04885998
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
NCT04885998, Phase 1, Completed, Amgen; results first posted 2024-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC). Trials, record NCT04885998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04885998
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
- NCT number
- NCT04885998
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Small Cell Lung Cancer
- Interventions
- Tarlatamab, AMG 404
- First posted
- 2021-05-13
- Last updated
- 2025-09-29
- Other registries' IDs
- eudract:2020-005957-26
- Results first posted
- 2024-10-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | First dose of tarlatamab up to 28 days | A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0: * Grade 3 adverse event (AE) except for fatigue lasting \< 7 days, Grade 3 nonfebrile neutropenia that improved to ≤ Grade 1 within 3 weeks, endocrinopathies if managed with replacement therapy, Grade 3 nausea/vomiting or diarrhea for \< 72 hours, Grade 3 amylase or lipase values not associated with pancreatitis, Grade 3 hematologic laboratory abnormalities not clinically relevant, or Grade 3 electrolyte abnormality up to 72 hours. * Grade 4 AE except for Grade 4 nonfebrile neutropenia lasting ≤ 7 days, Grade 4 electrolyte abnormality lasting up to 72 hours, Grade 4 amylase or lipase values not associated with pancreatitis, or Grade 4 hematologic laboratory abnormalities no clinically relevant. * Grade 5 AE * Recurrent Grade ≥ 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any TEAEs: From first IP dose up to last dose + 65 days or EOS, median duration was 4.2 months; TEAEs for EP: From last dose + 65 days up to snapshot date (15 November 2024), death, or last dose + 145 days or EOS, median duration was 2.6 months | An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (IP; tarlatamab) up to 65 days after the last dose of tarlatamab or AMG 404 or the end of study (EOS), whichever was earlier. A TEAE for the EP was an AE that occurred after the 65th day after the last dose of tarlatamab or AMG 404 up to 145 days after the last dose of tarlatamab or AMG 404 or end of study, whichever was later. A treatment-related AE was any TEAE where there was a reasonable possibility that the TEAE could have been caused by tarlatamab or AMG 404. Any clinically significant changes in vital signs, physical examinations, electrocardiograms, and clinical laboratory tests were included as TEAEs. |
| Secondary | Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified 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. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. Exact 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. |
| Secondary | Duration of Response Per Modified RECIST v1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The duration of response was defined as the time from first evidence of CR or PR to progressive disease (PD) or death due to any cause, whichever occurred first, estimated via Kaplan-Meier methods. 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. Confirmation scans were required within 4 weeks of the first documented response of CR or PR. PD: radiologic detection of ≥ 20% increase in tumor burden relative to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or presence of new lesions. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Disease Control Rate Per Modified RECIST v1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The disease control rate was defined as the percentage of participants with a best overall response of a confirmed response (CR/PR) or stable disease (SD) while on the study as defined by modified 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. Confirmation scans were required within 4 weeks of the first documented response of CR or PR 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 | Progression-free Survival Per Modified RECIST v1.1 | From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months | Progression-free survival was defined as the interval from the earlier date of the first dose of IP to the earlier of PD per modified RECIST v1.1 or death due to any cause, estimated via Kaplan-Meier methods. PD: radiologic detection of ≥ 20% increase in tumor burden to nadir and ≥ 5 mm absolute increase, or unequivocal progression of non-index lesions, or the presence of new lesions. Confirmation scans were required within 4 weeks of the first documented response of CR or PR, and 4-6 weeks for PD. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Overall Survival | From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months | Overall survival was defined as the interval from the earlier date of the first dose of IP to the event of death due to any cause, estimated via Kaplan-Meier methods. Participants who were still alive were censored at the date last known to be alive. If the date last known to be alive was after the data cutoff date, the participant was censored at the analysis trigger date. 95% CIs were calculated using the Brookmeyer and Crowley method. |
| Secondary | Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose) | Cmax was obtained using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified. |
| Secondary | Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 15 (pre-dose) | Ctrough was obtained at the end of a dosing interval or just before the administration of the next planned dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified. |
| Secondary | Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose) | AUC0-336 was defined as the actual body exposure to the drug over time following administration of a dose, calculated from time zero to 336 hours post-dose using noncompartmental analysis, which was performed for tarlatamab PK parameter estimation. PK analysis is presented per dose received as pre-specified. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | First dose of tarlatamab up to 28 days | The DLT analysis set included all enrolled participants who received at least 1 dose of tarlatamab or AMG 404 during the dose exploration part of the study with an evaluable DLT endpoint. DLT evaluable endpoints included: 1. participant experienced a DLT; or 2. participant did not experience a DLT and received tarlatamab or AMG 404 treatment as planned in cycle 1 and had been followed for safety events a minimum of 28 days from the date of first dose administration of tarlatamab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any TEAEs: From first IP dose up to last dose + 65 days or EOS, median duration was 4.2 months; TEAEs for EP: From last dose + 65 days up to snapshot date (15 November 2024), death, or last dose + 145 days or EOS, median duration was 2.6 months | The safety analysis set included all participants who received at least 1 dose of tarlatamab or AMG 404. For any TEAEs, categories included those that occurred before or during the EP. For the EP, data are presented for participants who entered the EP. Participants with snapshot date (15 November 2024) or death or EOS within the last dose date + 65 days were excluded from the EP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Per Modified RECIST v1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). Data is presented for participants who achieved a best overall response of PR or CR. | months | MEDIAN |
| SECONDARY | Disease Control Rate Per Modified RECIST v1.1 | From first dose of IP up to a minimum of last dose date + 65 days or EOS; median (min, max) duration was 4.2 (0.4, 25.4) months | The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival Per Modified RECIST v1.1 | From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months | The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). | months | MEDIAN |
| SECONDARY | Overall Survival | From first dose of IP up to a minimum of EOS or death; median (min, max) time was 9.4 (0.4, 25.5) months | The safety analysis set included all participants who received at least 1 dose of IP (tarlatamab or AMG 404). | months | MEDIAN |
| SECONDARY | Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose) | The pharmacokinetic (PK) analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available at each timepoint are presented. | micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 15 (pre-dose) | PK analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available are presented. | micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404 | Cycle 2 Day 1 (pre-dose up to 7 days post-dose); Cycle 2 Day 15 (pre-dose up to 14 days post-dose) | PK analysis set included all participant who had received at least 1 dose of tarlatamab and had at least 1 PK sample collected. Participants with data available at each timepoint are presented. | hours*micrograms per milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 0 | Participants | ||
| Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 1 | Participants | ||
| Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | 1 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | Any TEAE | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | Any TEAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 | Any TEAE | 8 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | Any tarlatamab-related TEAE | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | Any tarlatamab-related TEAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | Any tarlatamab-related TEAE | 3 | Participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 7 | |
| Overall Study | STARTED | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 5 | |
| Overall Study | STARTED | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | 3 | |
| Overall Study | STARTED | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 | 8 | |
| Overall Study | Safety Analysis Set | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 7 | |
| Overall Study | Safety Analysis Set | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 5 | |
| Overall Study | Safety Analysis Set | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | 3 | |
| Overall Study | Safety Analysis Set | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 | 8 | |
| Overall Study | Entered Extended Safety Period (EP) | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 6 | |
| Overall Study | Entered Extended Safety Period (EP) | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,048
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 | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 2 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 (EP) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/B + AMG 404 | 3 | 8 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 0 | 7 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 0 | 6 |
1 to 10 of 1,048Source ClinicalTrials.gov
See all 1,048 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 1 | 7 |
| Total, all-cause mortality | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 1 | 6 |
| Total, all-cause mortality | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 | 1 | 5 |
| Total, all-cause mortality | Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP) | 0 | 1 |
| Total, all-cause mortality | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 | 1 | 3 |
| Total, all-cause mortality | Part 1 Cohort 3: Tarlatamab Dose A/Dose D + AMG 404 (EP) | 1 | 1 |
| Total, all-cause mortality | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 2 | 4 |
| Total, all-cause mortality | Part 2 Dose Expansion Cohort: Tarlatamab Dose A/B + AMG 404 | 0 | 8 |
| Total, other adverse events | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 | 7 | 7 |
| Total, other adverse events | Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP) | 1 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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.
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