Non-small Cell Lung CancerPhase 1NCT04822298
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
A Phase 1 study testing AMG 160 in people with Non-small Cell Lung Cancer and NSCLC, run by Amgen at 4 sites in 3 countries.
Trial summary
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, NSCLC
- What is being tested?
- AMG 160
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 Aug 2021to 26 Jan 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
- Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
- With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
- Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
- Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.
Who cannot join
- Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- History of hemoptysis within 3 months prior to first dose.
- History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
- Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to start of dosing.
- Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
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- Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
- Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
- Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
- Any biological therapy or immunotherapy within 3 weeks of start of first dose.
- Major surgery within 4 weeks of first dose.
- Infection requiring IV antimicrobials for management within 7 days of dosing.
- Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
- Active autoimmune disease
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Austria2 sites
Landeskrankenhaus Salzburg
Salzburg, 5020
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).
- Conditions
- Non-small Cell Lung Cancer, NSCLC
- Being tested
- AMG 160
- Keywords
- AMG 160, Phase 1b
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 160Drug
AMG 160 administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Exploration | Experimental | The dose exploration part of the study will estimate the MTD and/or the RP2D. Receives: Drug: AMG 160 |
| Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC | Experimental | Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study. Receives: Drug: AMG 160 |
| Part 2: Dose Expansion - Cohort 2 Squamous NSCLC | Experimental | Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study. Receives: Drug: AMG 160 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)
DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment.
Measured: Day 1 to Day 28
Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment.
Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE.
Measured: Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days
Secondary outcomes (9)
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR per modified RECIST v1.1 was defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment.
- CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm.
- PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later.
Exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Overall Survival (OS)
Overall survival (OS) was defined as the time from the date of study Day 1 until death due to any cause. OS time (months) = (date of death - study Day 1 + 1) x 12/365.25.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and percentiles were using Greenwood's formula to estimate the standard error of the landmark estimates using the method by Kalbfleisch and Prentice (1980).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1
Radiographic PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a radiographic progressive disease (PD) or death from any cause, based on investigator assessment; otherwise, radiographic PFS was censored at the last evaluable tumor assessment date.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Clinical PFS Per Modified RECIST v1.1
Clinical PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a clinical PD or death from any cause, based on investigator assessment; otherwise, clinical PFS was censored at the last evaluable tumor assessment date.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Response Per Modified RECIST v1.1
Time to response per modified RECIST v1.1 was defined as the interval from study Day 1 to the either CR or PR based on investigator assessment.
- CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm.
- PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later.
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Progression Per Modified RECIST v1.1
Time to progression per modified RECIST v1.1 was defined as the interval from study Day 1 to PD, based on investigator assessment. Time to progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Clinical Progression
Time to clinical progression was defined as the interval from study Day 1 to PD. Time to clinical progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1.
- PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Duration of Response (DOR) Per Modified RECIST v1.1
DOR was defined as the time from the date of an initial objective response per modified RECIST v1.1 to the earlier of soft-tissue progression or death based on investigator assessment.
- CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm.
- PR: Decrease of 30% or greater in tumor burden compared with baseline.
CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan.
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Subsequent Therapy
Time to subsequent therapy was defined as the time from study Day 1 to the time a participant started/received the subsequent cancer therapy/subsequent therapy; otherwise time to subsequent therapy was censored at the last known date of any of the study assessment prior to initiating the subsequent cancer therapy/subsequent therapy.
Subsequent therapy was defined any anti-cancer therapies intended to treat NSCLC, or any other anti-cancer therapies started after ending study treatment and prior to End of Study.
Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982).
Measured: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start31 Aug 2021
- Primary completion8 Dec 2021
- Study completion26 Jan 2022
Why it stopped: Amgen made a business decision to discontinue AMG 160 20180273
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822298
- Sponsor's protocol ID
- 20180273
- Status last verified
- Jan 2024
- First submitted
- 26 Mar 2021
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04822298
- Acronym / sponsor ID
- 20180273
- Conditions
- Non-small Cell Lung Cancer, NSCLC
- Keywords
- AMG 160, Phase 1b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen made a business decision to discontinue AMG 160 20180273
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Exploration | Experimental | Drug: AMG 160The dose exploration part of the study will estimate the MTD and/or the RP2D. |
| Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC | Experimental | Drug: AMG 160Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study. |
| Part 2: Dose Expansion - Cohort 2 Squamous NSCLC | Experimental | Drug: AMG 160Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
- Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
- With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
- Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
Key exclusion criteria (15 listed)
- Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- History of hemoptysis within 3 months prior to first dose.
- History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
- Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to start of dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 160AMG 160 administered as an intravenous (IV) infusion | Drug | Part 1: Dose Exploration, Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC, Part 2: Dose Expansion - Cohort 2 Squamous NSCLC |
Primary outcome
Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)
Time frame: Day 1 to Day 28
DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment.
Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)
Time frame: Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment. Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE.
9 secondary outcomes
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Overall Survival (OS)
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Clinical PFS Per Modified RECIST v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Response Per Modified RECIST v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Progression Per Modified RECIST v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Clinical Progression
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Duration of Response (DOR) Per Modified RECIST v1.1
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Time to Subsequent Therapy
Time frame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 160 in people with Non-small Cell Lung Cancer and NSCLC, run by Amgen at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT) (time frame: Day 1 to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.