CLINICAL TRIAL

AGuIX for Carcinoma, Non-Small-Cell Lung

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new type of radiation therapy may help treat pancreatic and lung cancer.

See full description

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

Eligible Conditions
Lung Neoplasms · Carcinoma, Non-Small-Cell Lung · Pancreatic Neoplasms · Advanced Pancreatic Adenocarcinoma · Ductal Adenocarcinoma of the Pancreas · Non-small Cell Lung Cancer · Adenocarcinoma · Unresectable Pancreatic Cancer

Treatment Groups

This trial involves 3 different treatments. AGuIX 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 & 2 and have already been tested with other people.

Experimental Group 1
Radiotherapy
RADIATION
Experimental Group 2
Radiotherapy
RADIATION
+
AGuIX
DRUG
Experimental Group 3
Radiotherapy
RADIATION
+
AGuIX
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2510
AGuIX
2016
Completed Phase 1
~20

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:
nsclc patients who have no evidence of nodal involvement and who are determined to be unresectable or medically inoperable are eligible for the study. show original
Locally advanced, unresectable pancreatic cancer that has spread to the small intestine or veins near the pancreas show original
Pancreatic or central NSCLC tumors measuring ≤ 5cm. show original
The age requirement is 18 years or older. show original
Patients should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer that is defined as within or touching the zone of the proximal bronchial tree, which is defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi) show original
The subject has an ECOG performance status of ≤2, indicating that they are able to carry out everyday activities (Karnofsky ≥60%). show original
A tumor that is confirmed to be pancreatic ductal adenocarcinoma by either a histologic or cytologic examination of the tumor show original
The participants must have a disease that can be accurately measured in at least one dimension show original
There is no evidence of distant metastasis. show original
The study patient must have completed at least 3 months of standard induction chemotherapy for LAPC show original
View All
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: Baseline through study completion, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline through study completion, an average of 1 year.
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 AGuIX will improve 2 primary outcomes and 10 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 90 days.

Serious Adverse Events at 90 Days
90 DAYS
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
90 DAYS
Maximum tolerated dose (MTD) Phase 1
3 MONTHS
Evaluated by the occurrence of Dose Limiting Toxicity (DLT) over the duration of the study using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
3 MONTHS
Serious Adverse Events at 12 months
12 MONTHS
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
12 MONTHS
Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2
12 MONTHS
Evaluate SMART + AGuIX local control at 12 months compared to SMART alone. Local control at 12 months is defined as the treated tumor is equal to or less than the tumor volume at start of SMART. Progression would be defined per RECIST criteria
12 MONTHS
Progression-free survival (PFS) at Maximum tolerated dose (MTD)
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS
Assessed by RECIST criteria
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS
Compare overall survival
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS
Bayesian hierarchical two-sample test for binary outcomes
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS
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Who is running the study

Principal Investigator
J. L.
Jonathan Leeman, MD
Dana-Farber Cancer Institute

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

The signs of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) are often vague; therefore, there may be a delay between the detection of signs and symptoms and cancer diagnosis. Lung cancer may share signs with other diseases, including, for example, pulmonary embolism and pneumonia. It is essential for clinicians to work with patients to identify these signs.

Anonymous Patient Answer

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

The U.S. is ranked third in the world in the number of lung cancer cases diagnosed each year. A significant amount of smoking-related lung cancer deaths occur in the U.S. Each year, approximately 32,000 people will die from lung cancer in the U.S. Approximately 80% of those who die from lung cancer in the U.S. are non-smokers. The U.S. is also ranked second in the number of colon cancer cases annually. For this disease, smoking-related cases account for nearly half of all patients, and approximately 35% of all deaths from colon cancer. Each year, approximately 46,000 people will die from colon cancer in the U.S.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

We conclude that the lung has a higher rate of malignancy than other abdominal organs. Adenocarcinoma is the most common form of lung cancer, and is more prevalent in males than in females. We also conclude that, when present, tumor markers cannot be used as surrogates for pathologic evaluation. The high rate of pleural, hilar, and pericardial metastases is of relevance for physicians of patients with nonsmall-cell lung cancers.

Anonymous Patient Answer

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

Common treatments for carcinoma of the lung include surgery, chemotherapy, and radiotherapy. The majority of lung cancers are currently diagnosed incidentally, but this does not preclude the use of appropriate staging tests, such as computed tomographic (CT) scanning. More importantly, clinical stage, metastasis, and prognosis for stage IV carcinoma are now defined. Overall survival is low with stage IV disease. Most patients with advanced lung cancer are candidates for active treatment with anticancer therapies.

Anonymous Patient Answer

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

A minority (7 of 43) of patients with non-small-cell lung carcinoma were enrolled in a randomized, double blind, placebo-controlled trial. The average survival of the patients on the treatment arm was 9.7 months compared to the control arm on average survival of 5.6 months (p<0.02. Significant improvement of median survival for patients with an adenocarcinoma, with the addition of prophylactic therapy on docetaxel to conventional therapy, who had resectable disease, was achieved.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Cervical cancer screening may decrease the incidence of carcinoma, non-small-cell lung by as much as 35%; however, the benefit has not yet been shown. On the other hand, no evidence supports mammographic screening of women 65 years or older reduces the incidence of non-small-cell lung cancer; however, the benefit of screening for lung cancer in this age group is significant.

Anonymous Patient Answer

Have there been other clinical trials involving aguix?

Clinical trials will continue to be required to find out the mechanism of action of aguix and to establish it as a drug which is useful for treating cancer as a monotherapy or in combination with other drugs. Clinical trials on aguix for cancer treatment are also likely to involve clinical trials on combination use with other drugs to find the most effective dosage for each combination use.

Anonymous Patient Answer

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

The odds of developing NSCLC increased for all variables in any of the age intervals analyzed (≤35 years, 36-50 years, 51-75 years, and>76 years). For women and men, these odds ratios were 1.37 (95% CI = 1.23,1.55) and 1.35 (95% CI = 1.24,1.47), respectively. We were unable to examine the effect of smoking history because of a small number of cases. Results from a recent paper are not consistent with findings by the National Cancer Registry in the United States, in which no odds ratios for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) were observed at any age interval.

Anonymous Patient Answer

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

Aguix has been successfully evaluated for several indications in clinical cancer trials. It has also been found to have beneficial effects on QOL for cancer patients. These observations are consistent with data in general supportive care and complementary medicine trials of patients with cancer, which are also designed to evaluate the effect of aguix on QOL in cancer patients.

Anonymous Patient Answer

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

There is no consensus on whether patients with carcinoma, non-small-cell lung, should be treated like younger patients, with more radical surgery and postoperative radiation, or like elderly patients, with less radical surgery and no postoperative radiation. Although recent studies also disagree on how to treat carcinoma, non-small-cell lung as a group, the overall mean age of patients with carcinoma, non-small-cell lung, was 66 for patients with local control and 63 for patients who died of non-carcinoma causes.

Anonymous Patient Answer

What is aguix?

In the [Colombian city] San Miguel de Aguayo, where aguix is popular in the festivities in honor of the patron saint of this city, women used the traditional, handmade artisanal silver and gold utensil, made by an artisan to adorn their faces in the [festival], known as "Tiempo Aguayo", because women are believed to be the most beautiful in the city. We also find [them] wearing the jewelry that makes them look elegant to us as women or children.

Anonymous Patient Answer

What is the latest research for carcinoma, non-small-cell lung?

Non-small-cell lung carcinoma has been the most serious malignancy in young and middle-aged adults in the United States over the past decade. Although the cancer death rate has steadily decreased in older adults, the American Cancer Society  estimates it has  risen between 1985 and 2016. [Power](http://www.withpower.com/clinical-trials/carcinoma, non-small-cell lung) makes it easier to find non-small-cell lung cancer clinical trials tailored to your condition, treatment, or location.

Anonymous Patient Answer
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