Trial Outcomes & Findings for Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (NCT NCT04822298)

NCT ID: NCT04822298

Last Updated: 2024-07-05

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: Day 1 to Day 28
• Results posted on: 2024-07-05

Participant Flow

This study was conducted at 2 centers in Australia and Austria between 31 August 2021 and 26 January 2022.

The study was terminated early due to sponsor decision after 3 participants were enrolled into Cohort 1 of Part 1 (dose exploration); no participants were screened or enrolled for additional Part 1 or Part 2 (dose expansion) cohorts.

Participant milestones

Measure	Part 1: AMG 160 Cohort 1 AMG 160 was administered as a short-term intravenous (IV) infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Part 1: AMG 160 Cohort 1 AMG 160 was administered as a short-term intravenous (IV) infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Overall Study Death	3

Baseline Characteristics

Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Age, Continuous	58.0 Years STANDARD_DEVIATION 3.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28

Population: DLT analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160 with an evaluable DLT endpoint. The DLT endpoint is evaluable if either: 1) the participant experienced a DLT, or 2) the participant did not experience a DLT after receiving all planned doses within the 28-day DLT window.

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.

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)	1 Participants

PRIMARY outcome

Timeframe: 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

Population: Safety analysis set: defined as all participants that were enrolled and receive at least 1 dose of AMG 160.

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.

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Number of Participants Who Experience One or More Treatment-emergent AE (TEAE) Any TEAEs	3 Participants
Number of Participants Who Experience One or More Treatment-emergent AE (TEAE) Any treatment-related TEAEs	3 Participants

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: RECIST v1.1 evaluable analysis set: defined as all participants that are enrolled, receive at least 1 dose of AMG 160 and had measurable baseline disease per RECIST 1.1 per protocol and had the opportunity to be followed for at least 9 weeks starting from study Day 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.

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	0.0 Percentage of Participants Interval 0.0 to 70.76

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160.

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).

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Overall Survival (OS)	3.29 Months Interval 3.09 to Upper limit of the 95% CI was not reached.

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160.

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).

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1	3.29 Months Interval 1.51 to Upper limit of the 95% CI was not reached.

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160.

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).

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Clinical PFS Per Modified RECIST v1.1	3.09 Months Interval 3.09 to Upper limit of the 95% CI was not reached.

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. Analyzed in participants with an objective response.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160.

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).

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Time to Progression Per Modified RECIST v1.1	3.29 Months Interval 1.51 to Upper limit of the 95% CI was not reached.

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160.

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).

Outcome measures

Measure	Part 1: AMG 160 Cohort 1 n=3 Participants AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Time to Clinical Progression	NA Months Interval 3.09 to Median and upper limit of the 95% CI were not reached.

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: RECIST v1.1 evaluable analysis set: defined as all participants that are enrolled, receive at least 1 dose of AMG 160 and had measurable baseline disease per RECIST 1.1 per protocol and had the opportunity to be followed for at least 9 weeks starting from study Day 1. Analyzed in participants with an objective response.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Median (min, max) time from first dose to end of study was 100 (94, 122) days

Population: Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. Analyzed in participants who received 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).

Outcome measures

Outcome data not reported

Adverse Events

Part 1: AMG 160 Cohort 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	Part 1: AMG 160 Cohort 1 n=3 participants at risk AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Eye disorders Uveitis	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.

Other adverse events

Measure	Part 1: AMG 160 Cohort 1 n=3 participants at risk AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Eye disorders Eyelid oedema	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Vomiting	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Fatigue	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Immune system disorders Cytokine release syndrome	100.0% 3/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Conjunctivitis	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Vascular access complication	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Alanine aminotransferase increased	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Gamma-glutamyltransferase increased	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Headache	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Lethargy	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Taste disorder	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Eczema	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: 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. Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER