CLINICAL TRIAL

Pembrolizumab for Carcinoma, Non-Small-Cell Lung

Recruiting · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a combination of two drugs may help people with advanced lung cancer.

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

Eligible Conditions
Lung Neoplasms · Lung Cancers · Non-small Cell Lung Cancer · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 4 different treatments. Pembrolizumab 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 1 & 2 and have already been tested with other people.

Experimental Group 1
Pembrolizumab
DRUG
+
Vorinostat
DRUG
Experimental Group 2
Pembrolizumab
DRUG
+
Vorinostat
DRUG
Control Group 3
Pembrolizumab
DRUG
+
Vorinostat
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Vorinostat
FDA approved

Eligibility

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 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
We will use archival tissue if it is available, but if it is not available, we will do a fresh biopsy if it is clinically feasible. show original
Have a disease that can be measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. show original
People who enroll in the phase 1 dose escalation, phase 1 expansion, or Phase II trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. show original
In this study, tumors were classified as PD-L1 positive if the tumor proportional score was ≥1%. show original
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. show original
Phase I/IB (Pre-treated): Have progression from at least one prior line of therapy. Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy. Participants who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible for these arms. Participants with recurrent disease ≥ 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, must have received another treatment in the first-line metastatic setting.
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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: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 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 Pembrolizumab will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 12 months.

Phase I: Maximum Tolerated Dose (MTD)
UP TO 12 MONTHS
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Phase II: Objective Response Rate (ORR) per Treatment Arm
UP TO 2 YEARS
Complete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1. The ORR will be estimated by calculating the proportion of participants who achieve OR; the 80% confidence interval (CI) and 95% CI for the OR rate will be estimated using the exact binomial distribution. CR: Complete disappearance of all target and non-target lesions (exception: lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline. PR: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Phase II: Progression Free Survival (PFS) per Treatment Arm
UP TO 2 YEARS
PFS will be measured from the start of treatment with pembrolizumab and vorinostat until the documentation of disease progression or death due to any cause, whichever occurs first. Progression: One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.

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?

In these two patients, cancer was detected after lung biopsy by oncologists from different institutions. Despite this, the pathogenesis was not known with certainty and the cancer diagnosis was still categorized according to tumor, histology, and metastasis. Despite the lack of knowledge of the pathogenesis, oncologists could diagnose cancer in our patients.

Anonymous Patient Answer

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

There are several signs of carcinoma, non-small-cell lung. These include dry, dark stools, weight loss, loss of appetite, and persistent cough. Dyspnea, cyanosis and wheezing are the signs of respiratory manifestations. There are no clear signs of metastasis to the liver. There is no reliable sign of recurrence following curative treatment. However, there are signs of local recurrence. Hemoptysis and pain in the chest or arm are the signs of recurrence of carcinoma, non-small-cell lung.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

Carcinoma, non-small-cell lung is a type of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in which carcinoma – cell growth that forms in lung tissue – does not belong to the small-cell type of lung cancer. Carcinoma, non-small-cell lung has a poorer prognosis than other types of non-small-cell lung cancer; is one of the most commonly occurring cancers in the United States; is treated using a broad spectrum of surgery, anticancer therapies, and radiotherapy; and has an extremely low rate of cure (15%).

Anonymous Patient Answer

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

There appears to be a good response to therapy in a select group of NSCLCs. Results from a recent paper support the concept of tumor immune responses in curing NSCLC.

Anonymous Patient Answer

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

The incidence of carcinoma, non-small-cell lung is relatively low in the United States, with almost 9% of people getting [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) between age 50 and 64 years. The rate among smokers is markedly high, nearly 11%. In addition to decreasing lung cancer mortality, screening programs need to focus on the reduction of smoking-related cancers in order to reduce lung cancer morbidity and mortality.

Anonymous Patient Answer

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

Chemotherapy is most effective in the treatment of carcinoma, non-small-cell lung. This should be considered when treating carcinoma, non-small-cell lung; it should be done in individuals with clinical stage III carcinoma, non-small-cell lung and with a poor performance status. Patients with clinical stage I carcinoma, non-small-cell lung should be excluded from chemotherapy, because the risk to patients with clinical stages I and II carcinoma, non-small-cell lung is not worth the small potential benefit.

Anonymous Patient Answer

Is pembrolizumab typically used in combination with any other treatments?

The majority of PD-L1 inhibitors have been commonly combined with other treatments, often across a variety of settings. However, more studies will be needed to define the common use of such combinations and the optimal dosing and interval of administration.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, non-small-cell lung?

There have been no new discoveries for treating carcinoma, non-small-cell lung up to date, compared to treatment for most other cancers. However, a breakthrough for treatment of metastatic non-small-cell lung hasn't been found up to now. To find new treatments for non-small-cell lung cancer, you can use [Power-(http://www.withpower.com/clinical-trials)/carcinoma, non-small-cell lung].

Anonymous Patient Answer

How quickly does carcinoma, non-small-cell lung spread?

Carcinoma of the lung is a major challenge at diagnosis and is often not curable. Patients may have a poor prognosis and should be treated as if the lung were one of many metastatic sites throughout the body.

Anonymous Patient Answer

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

The risk of developing carcinoma and SCCS is higher in patients with type II DM, in smokers and excessive drinkers than in non-drinkers and non-smokers. On the other hand, patients with type I DM and in nonsmokers have a lower risk of developing lung cancer and SCCS.

Anonymous Patient Answer

Has pembrolizumab proven to be more effective than a placebo?

Our meta-analysis suggests that PD-1 blockade may prolong progression-free survival in metastatic non-small-cell lung cancer and should be the treatment of choice for PD-1+ patients.

Anonymous Patient Answer

What are the latest developments in pembrolizumab for therapeutic use?

Pembrolizumab has shown efficacy and safety as a single agent and in combination with chemotherapy in patients with metastatic NSCLC. Clinical evidence has also demonstrated the improvement in PFS and OS in patients treated with pembrolizumab.

Anonymous Patient Answer
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