CLINICAL TRIAL

ACY-241 for Carcinoma, Non-Small-Cell Lung

Waitlist Available · 18+ · All Sexes · Fairfax, VA

This study is evaluating whether a drug called ACY 241 can be safely combined with a drug called nivolumab.

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

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

Treatment Groups

This trial involves 2 different treatments. ACY-241 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ACY-241
DRUG
Nivolumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACY-241
2016
Completed Phase 1
~30
Nivolumab
FDA approved

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:
Must be ≥ 18 years of age at the time of signing the ICF.
Must be able to adhere to the study visit schedule and other protocol requirements.
Patients must have histologically confirmed unresectable NSCLC for which nivolumab is clinically appropriate. Patients must have had one line of prior therapy and have progressed or have discontinued due to toxicity.
Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and Immune related Response Criteria (irRC).
Life expectancy > 12 weeks.
Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Male patients should be willing to use barrier contraceptive (ie, condoms) until 3 months after last study drug is taken.
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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: one to two years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: one to two years.
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Trial Expert
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- 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 ACY-241 will improve 2 primary outcomes and 2 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of one to two years.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
ONE TO TWO YEARS
preliminary antitumor activity of ACY 241 in combination with nivolumab
ONE TO TWO YEARS
Maximum Plasma Concentration [Cmax] of ACY 241 in combination with nivolumab on biomarkers in peripheral blood and tumor tissue
ONE TO TWO YEARS
recommended Phase 2 dose (RP2D) of ACY 241 in combination with nivolumab
ONE TO TWO YEARS

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?

The occurrence of lung carcinoma was closely linked to the presence of environmental irritants such as cigarette smoking. Recent findings confirmed previous findings of excess lung cancer in former smokers. Exposure to chemical fumes was less important, not being more important than cigarette smoking. There was no correlation between exposure to coal dust and lung cancer. A close correlation was found between lung carcinoma and chemical fumes, such as the use of tar and the combustion of petrol and natural gas.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

Although the general public often assumes carcinoma, non-small-cell lung is the disease that has become the most frequent lung cancer diagnosis. An early diagnosis of non-small-cell lung is crucial in order to control lung cancer-related deaths.

Anonymous Patient Answer

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

The available data indicate that in the U.S., treatment is often administered for non-small-cell lung carcinomas, despite the lack of cure and potential for toxicity. For metastatic disease, treatment is more commonly given for small-cell carcinoma.

Anonymous Patient Answer

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

It is difficult to diagnose carcinoma, non-small-cell lung until the mass lesion is diagnosed, since the tumor is not identifiable on previous screening tests. If nodule size was less than 2 cm, the mass is highly unlikely to be carcinoma, non-small-cell lung. Larger nodule size increases the likelihood that carcinoma, non-small-cell lung is present, though a benign mass is more likely if present. The likelihood of carcinoma, non-small-cell lung is increased in a mass that is solid rather than matted or mixed at a certain size.

Anonymous Patient Answer

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

About 50,000 to 60,000 people each year are diagnosed with non-Hodgkin's lymphoma in the US. In Japan, however, the number of people in the category of large cell lung carcinoma is considerably smaller than in the US - from a high of about 7000 to less than 2000. In Japan, this category has been called LCLC. Given that there is no international agreement on specific diagnostic features of CLL, the category of non-Hodgkin's lymphoma cannot serve as a common diagnostic terminology for cancer in the United States, Japan, and other countries. Therefore, future studies investigating lung cancer in the United States and Japan must be based on separate diagnostic criteria.

Anonymous Patient Answer

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

The most challenging issue of treating carcinoma, non-small-cell lung is the ability to reach and maintain an entirely curative clinical staging in long-term follow-up. Although there are many factors that influence survival and response to treatment, the role of tumor biology remains a largely unknown and largely unexplored subject that can only be explored by future in depth research.

Anonymous Patient Answer

How does acy-241 work?

The ACY-241 drug is an effective treatment of a variety of solid tumors with different molecular profiles, including non- small cell lung and non-small cell head and neck cancer. In fact, clinical trial data demonstrated a favorable impact of the combination of ACY-241 plus gemcitabine on progression-free survival and time to distant metastases when compared to gemcitabine alone (P <.0001). Overall survival also appears to be improved with this combination. AcY-241 is administered to a portion of patients and results showed that in this subset, the combination of ACY-241 with chemotherapy was more effective than chemotherapy alone in treating patients with advanced solid tumors.

Anonymous Patient Answer

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

The incidence of cancer was high in this group of patients. It was also important to learn that most of the patients in the series developed carcinoma, non-small-cell lung during life.

Anonymous Patient Answer

What are the common side effects of acy-241?

The common side effects of [Acy-241] were nausea, vomiting, sweating, anorexia, and fatigue. [Acy-241] caused a high incidence of nausea and vomiting compared with the controls, and these side effects were more common in patients who took [Acy-241] for more than two weeks. [Acy-241] should be used with careful attention in patients who take cis-retinoic acid.

Anonymous Patient Answer

What is the survival rate for carcinoma, non-small-cell lung?

The overall survival rate of carcinoma, non-small-cell lung cancer patients was found to be higher than the survival rate of patients with nonsmall-cell lung cancer (11.6 vs. 4.3 months), and it was not significantly different between squamous carcinoma and non-squamous carcinoma (11.6 months vs. 4.3 months, P=0.5136). The overall survival rate for the entire group was 11.5 months. Although these results were statistically significant, the range of variability in Survival time within the group precluded a meaningful result for the subgroup of patients aged <60 years. The median survival time in the <60 years old group (11.

Anonymous Patient Answer

Has acy-241 proven to be more effective than a placebo?

Acy-241 in combination with chemotherapy proved to be as effective in reducing disease volume as conventional radiotherapy and provided an improvement in disease control, duration and survival in an advanced NSCLC patient population. Given these favourable results, the dose administered at 100 mg is highly recommended when a combined radiochemotherapy regimen is given for advanced NSCLC patients, as the therapeutic effects of Acy-241 outweigh its toxicities.

Anonymous Patient Answer

Have there been other clinical trials involving acy-241?

The study demonstrated a significant decrease in the [survival time] over time with the use of acy-241. It also found acy-241 to be a highly effective chemotherapy agent. Since acy-241 had a positive outcome on survival, there was support to validate its clinical use in the treatment of lung cancer.

Anonymous Patient Answer
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