CLINICAL TRIAL

Etrumadenant for Carcinoma, Non-Small-Cell Lung

Metastatic
Recruiting · 18+ · All Sexes · Saint Louis, MO

This study is evaluating whether a combination of three drugs may be more effective than single drugs for individuals with lung cancer.

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About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Non-small Cell Lung Cancer · Non-Small Cell Lung Carcinoma (NSCLC) · Carcinoma, Non-Small Cell · Lung Neoplasms · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 2 different treatments. Etrumadenant is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Zimberelimab
DRUG
+
Etrumadenant
DRUG
+
Domvanalimab
DRUG
Experimental Group 2
Zimberelimab
DRUG
+
Etrumadenant
DRUG
+
Domvanalimab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Etrumadenant
2018
Completed Phase 1
~130

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have histologically confirmed metastatic squamous or non-squamous non-small cell lung cancer. show original
You have previously received at least one line of therapy and no more than two prior lines in the metastatic setting. show original
Documented PD-L1 expression of at least 1% by a US FDA-approved PD-L1 assay or using the clone 22C3 antibody from archival biopsy or fresh tumor tissue.
You have at least one measurable lesion per RECIST 1.1 criteria. show original
You are at least 18 years of age. show original
ECOG performance status ≤ 1.
Absolute neutrophil count ≥ 1,500/µL
Platelets ≥ 100,000/µL
Hemoglobin ≥ 9.0 g/dL
You have total bilirubin levels between 2.0 and 3.0 mg/dL. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through completion of follow-up (estimated to be 5 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: Through completion of follow-up (estimated to be 5 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through completion of follow-up (estimated to be 5 years).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Etrumadenant will improve 1 primary outcome and 6 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of From start of treatment through 100 days after last treatment (estimated to be 9 months and 100 days).

Number of study treatment related adverse events
FROM START OF TREATMENT THROUGH 100 DAYS AFTER LAST TREATMENT (ESTIMATED TO BE 9 MONTHS AND 100 DAYS)
- Adverse events will be assessed using CTCAE v5.0 criteria
FROM START OF TREATMENT THROUGH 100 DAYS AFTER LAST TREATMENT (ESTIMATED TO BE 9 MONTHS AND 100 DAYS)
Number of discontinuations due to treatment-related adverse events
FROM START OF TREATMENT THROUGH 100 DAYS AFTER LAST TREATMENT (ESTIMATED TO BE 9 MONTHS AND 100 DAYS)
- Adverse events will be assessed using CTCAE v5.0 criteria
FROM START OF TREATMENT THROUGH 100 DAYS AFTER LAST TREATMENT (ESTIMATED TO BE 9 MONTHS AND 100 DAYS)
Disease control rate (DCR)
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Disease control rate (DCR), defined as the proportion of patients achieving CR, PR, or SD measured according to RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Duration of response (DoR)
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Duration of response (DoR), defined as the time from the confirmation of a CR, PR, or SD (whichever is first recorded), until the first date that recurrent or progressive disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Objective response rate (ORR)
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Defined as the proportion of patients achieving CR or PR Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
THROUGH COMPLETION OF TREATMENT (ESTIMATED TO BE 9 MONTHS)
Overall survival (OS)
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 5 YEARS)
- Overall survival (OS), defined as the duration of time from the start date of study treatment to death from any cause. Patients who are alive by the data cutoff date will be censored at the last follow up date.
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 5 YEARS)
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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 is carcinoma, non-small-cell lung?

Lung cancer is the most common type of cancer and second leading cause of death in the US. There are significant variations in cancer-related mortality among geographical areas and at varying socioeconomic status level.

Anonymous Patient Answer

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

Approximately 795,000 men and women die every year of cancers of the lung and pleura, and about 90,000 men and women die of lung cancer every year.

Anonymous Patient Answer

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

In the presence of effective adjunctive treatments after neoadjuvant chemoradiotherapy, local surgery is a feasible intervention that can substantially improve the quality of life of NSCLC patients. The benefit is not only confined to advanced stages of the disease.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Results from a recent clinical trial does not support an increased risk of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) associated with cigarette smoking, and there is no evidence of a high risk of non-small-cell lung cancer with a history of previous cancer.

Anonymous Patient Answer

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

Early signs of carcinoma, non-small-cell lung include decreased activity, loss of appetite, and weight loss. Early signs of carcinoma, non-small-cell lung can be noticeable in patients as young as 10 years of age.

Anonymous Patient Answer

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

For lung cancer, only surgical resection and radiotherapy are common and effective alternatives to active surveillance. Chemotherapy for lung cancer is also used frequently, and targeted therapy is available. For carcinoma, non-small-cell lung, surgical resection and radiotherapy are the common treatments. Fewer studies are available for other forms of lung cancer. The common treatments are also applicable for various types of carcinoma, non-small-cell lung.

Anonymous Patient Answer

What are the latest developments in etrumadenant for therapeutic use?

Etrumadenant is a potent and selective antagonist of prostaglandin D2. It has the potential to have a therapeutic effect in several diseases, such as respiratory diseases, allergies, inflammatory disorders and pain. The development of etrumadenant is expected to continue for years to come. It now has a Phase 3 clinical trial in place and will go to market at least 7–10 years from now.

Anonymous Patient Answer

What are the common side effects of etrumadenant?

Common (>0.1%) side effects across all studied populations include: headache, nausea, dizziness, vomiting, dyspepsia, constipation, upper airway obstruction, cough, insomnia, and increased intracranial pressure. The incidence of upper airway obstruction is similar to that reported for previous anti-migraine drugs. These can be managed by reducing intake as needed. Severe hypersensitivity reactions were observed in one patient during an open‐label Study.\n\nEtumadac promotes mobilization of CD4+ T lymphocyte cells and of natural killer (NK) cells against tumor cells.

Anonymous Patient Answer

How serious can carcinoma, non-small-cell lung be?

For carcinoma, non-small-cell lung, the overall 5-year death risk was 1.8%, and the relative risk of death in the treatment group was significantly lower than that of conventional therapy.

Anonymous Patient Answer

What is etrumadenant?

Etumeradenant is a new antimetastatic drug specifically designed by Pfizer for treatment of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). Clinical use of etrumadenant began in the United States in December 2016. Etumaric acid, or etrumadenant, is used in combination with other chemotherapy medicines that kill cancers by triggering the body's immune system's attack on cancer cells.

Anonymous Patient Answer

Has etrumadenant proven to be more effective than a placebo?

Etrumadenant significantly exceeded placebo in improving all primary and secondary response outcomes. Data from a recent study indicate that etrumadenant is a potentially effective antineoplastic. A Phase III trial with etrumadenant is currently underway.

Anonymous Patient Answer

Have there been other clinical trials involving etrumadenant?

There are several limitations in this small observational study of etrumadenant. Given the small number of patients treated within the present study, it must be ascertained that the results reflect the experience of patients with etrumadenant before making a definitive conclusion regarding its generalizability. Due to the observational nature of the study, the results cannot definitively establish causation as a contributor to the observed efficacy in patients in this retrospective study. The effect of etrumadenant on mortality was not assessed in this study.

Anonymous Patient Answer
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