AMG 160 for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
+3 More
AMG 160 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

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

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Non-small Cell Lung Cancer
  • Lung Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether AMG 160 will improve 6 primary outcomes and 12 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 24 weeks.

28 days
Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)
Up to 24 weeks
Accumulation Ratio of AMG 160
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 160
Half-life (t1/2) of AMG 160
Maximum Serum Concentration (Cmax) of AMG 160
Minimum Serum Concentration (Cmin) of AMG 160
Up to 3 years
Duration of Response
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests
Number of Participants who Experience Clinically Significant Changes in Electrocardiograms (ECGs)
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)
Number of Participants who Experience One or More Treatment-related Adverse Events
Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Overall Survival
Progression-free Survival (PFS)
Time to Progression
Time to Response
Time to Subsequent Therapy

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC

This trial requires 50 total participants across 3 different treatment groups

This trial involves 3 different treatments. AMG 160 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC
Drug
Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
Part 1: Dose Exploration
Drug
The dose exploration part of the study will estimate the MTD and/or the RP2D.
Part 2: Dose Expansion - Cohort 2 Squamous NSCLC
Drug
Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Non-Small-Cell Lung or one of the other 3 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes carcinoma, non-small-cell lung?

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Lung cancer was associated with exposure to asbestos, tobacco smoking, family smoking history and environmental tobacco smoke. Although there is no clear evidence, it is believed that asbestos plays an essential role in the pathogenesis of lung cancer.

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What are common treatments for carcinoma, non-small-cell lung?

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Common treatments for carcinoma, non-small-cell lung involve surgery, chemotherapy, radiotherapy, and targeted therapy. There has not been an accurate identification of optimal treatment for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). In addition, the number of cancers diagnosed and the percentage of cases with metastases at the time of diagnosis in a given group of patients differ from group to group. Thus, a decision for treatment should be taken with consideration of the patients' age, overall clinical status, disease stage, and underlying pathology in each individual case.

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

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There is no evidence to suggest that carcinoma, non-small-cell lung is a curable disease. However, it is unlikely for lung carcinoma to be recurrent at the time of disease recurrence. Therefore, lung carcinoma cases with high TNM involvement grades should be considered for adjuvant treatment for recurrence at a later stage.

Unverified Answer

What are the signs of carcinoma, non-small-cell lung?

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Most of the lesions involved with carcinoma of the lung were detected on CT. Most of the lesions of carcinoma, non-small-cell lung did not involve the upper lobes. There was a higher percentage of consolidation in the lower lung fields, whereas pleural thickening and a halo sign were more frequently seen in the upper lobes. Thus, carcinoma, nontnepositive for cancer may present as an advanced carcinoma with a halo sign on CT.

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

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Approximately 3.8 million American adults are diagnosed with lung carcinoma each year. This makes up 4.1% of all adult neoplasms. Patients must be informed of the possibility of long-term cancer risk if lung carcinoma in situ is found at first bronchoscopy.

Unverified Answer

What is carcinoma, non-small-cell lung?

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Lung cancer is the third-leading cause of cancer-related death in women and second-leading cause or major cause of death for both women and men in the United States. The United States National Conference of Chief Medical Oncologists (NCOCM) published initial clinical guidelines for the diagnosis, treatment, and follow-up of patients with non-small-cell lung cancer in December, 2007. As such, this report is dedicated to the memory of Dr. Harold F. Fletcher, the late dean and CEO of the University of Pennsylvania School of Medicine and a leader in lung cancer treatment and research.

Unverified Answer

What is the primary cause of carcinoma, non-small-cell lung?

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The cause of cancer, non-small-cell lung is thought to originate in the bronchus and other branching parts of respiratory tract; therefore, lung cancer is the most common cancer in the lung. However, some studies showed different results. For example, some studies showed that tobacco was not the main cause of cancer, non-small-cell lung and others showed no relationship with cancer, as a causative factor of both lung cancer and lung cancer, non-small-cell lung. Therefore, it is necessary to investigate more precise causes of lung cancer, besides smokers. Although, smoking seems to be a risk factor in lung cancer, there is a need for more precise studies.

Unverified Answer

Have there been other clinical trials involving amg 160?

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We are still interested, as amg 160 in combination with dacarbazine is safe and effective in treating patients with advanced colorectal cancer. This phase II study provides further evidence to show that amg 160, given in a dose of 120 mg subcutaneously every 3 days in combination with dacarbazine 350 mg subcutaneously every 6 days, is safe and has activity in this disease. A similar trial using amg 160 combined with melphalan is currently ongoing. In addition, this compound has been tested as a possible treatment modality for patients with advanced NSCLC who are not eligible for traditional therapy based on EGFR mutations.

Unverified Answer

What is the average age someone gets carcinoma, non-small-cell lung?

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The incidence of lung carcinoma increases progressively after age 40 years; lung carcinoma is the second most frequently reported form of cancers after colorectal cancer.

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Is amg 160 safe for people?

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Amg 160 was generally well tolerated. Mild to moderate hepatic adverse events occurred in 3% of placebo and 5% of Amg 160 treatment sessions, in most cases reversible with treatment discontinuation (> or =6%) and not related to amg 161 content or dosage. There were no fatalities associated with Amg 160 in healthy subjects during an extensive safety evaluation. Overall mortality in cancer patients is about 2%, therefore, amg 160 would qualify as a probable carcinogen. An excess risk for malignancies and cancers of the liver might be expected to occur in patients concurrently receiving amg 160 with chemotherapy, but data to support this assumption do not yet exist.

Unverified Answer

What are the chances of developing carcinoma, non-small-cell lung?

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The risk of developing non-small-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is 3.6% per year among women and 1.8% per year among men (relative risk: 0.38). These estimates are comparable to the odds given in some recent lung cancer risk tables. Cancer of the pancreas is also a rare cancer among males (relative risk: 0.05) and very rare in females. These risks of developing lung cancer for men and for women must be taken into account when deciding whether to do a screening program for lung cancer.

Unverified Answer

Does amg 160 improve quality of life for those with carcinoma, non-small-cell lung?

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In patients with unresectable or recurrent carcinoma, amg 160 did not improve quality of life, compared with placebo. Results from a recent clinical trial support the recommendation of FDA for amg 160 to be approved for the treatment of non-small cell lung carcinoma.

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