Ipilimumab for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Local Institution - 0012, Stuttgart, Germany
Non-Small Cell Lung Carcinoma (NSCLC)+2 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the combination of two immunotherapy drugs may be more effective in treating lung cancer.

See full description

Eligible Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ipilimumab will improve 1 primary outcome and 8 secondary outcomes in patients with Non-Small Cell Lung Carcinoma (NSCLC). Measurement will happen over the course of Approximately 48 months.

Approximately 48 months
Disease Control Rate (DCR) of patient subgroups defined by baseline biomarkers
Duration of Response (DOR) of patient subgroups defined by baseline biomarkers
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Objective Response Rate (ORR)
Objective Response Rate (ORR) of patient subgroups defined by baseline biomarkers
Overall Survival (OS) of patient subgroups defined by baseline biomarkers
Progression Free Survival (PFS) of patient subgroups defined by baseline biomarkers
Time to Response (TTR) of patient subgroups defined by baseline biomarkers

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Combination therapy
1 of 1
Experimental Treatment

This trial requires 231 total participants across 1 different treatment group

This trial involves a single treatment. Ipilimumab 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 2 and have already been tested with other people.

Combination therapyNivolumab + Ipilimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 48 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 48 months for reporting.

Closest Location

Local Institution - 0006 - Springdale, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Non-Small Cell Lung Carcinoma (NSCLC) or one of the other 2 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Measurable disease by CT or MRI
You have non-small cell lung cancer and no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease. show original
You are able to carry out light house work or office work. show original

Patient Q&A Section

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

"Approximately 20,000 cases of nasopharynx carcinoma were diagnosed in 2009, with an incidence of 62.7/100,000 population, and a death rate of 1.0/100,000 population. Carcinoma, non-small-cell lung is the most common lung cancer, with a 7.1/1,000-incidence ratio, accounting for 20% of all lung cancer cases in 2009. The number of deaths of this type of lung cancer was 0.4/1,000-incidence ratio. The incidence of carcinoma, non-small-cell lung in the population increased dramatically in comparison with that 5 years ago." - Anonymous Online Contributor

Unverified Answer

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

"Patients with non-small-cell carcinoma of the lung are treated with surgery, radiation, chemotherapy, and sometimes hormonal therapy. For patients with non-small-cell cancer, the treatment is highly dependent on the stage and type of non-small-cell cancer." - Anonymous Online Contributor

Unverified Answer

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

"Abnormal lung sounds such as crackles and wheezing may be an early sign of lung cancer. Coughing up blood, loss of appetite, loss of weight and fatigue are associated with smoking or with a history of lung cancer." - Anonymous Online Contributor

Unverified Answer

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

"This is the first report of the cure of lung cancer in a patient with severe preexisting health problems, with radiochemotherapy and subsequent surgery. In a recent study, findings show that a poor prognosis is not a contraindication for cure. However, the long-term disease-free survivors have a limited rate of cure, which is probably due to the fact that this illness is chemo-, radioresistant." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"There is no clear mechanism (cause) for carcinoma of the lung. It is likely to be multifactorial including environmental exposures, smoking, genetic susceptibility and the expression of factors that facilitate tumoral growth and spread." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"In addition to the common types of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s, other types of cancer are of increasing importance. These include squamous-cell carcinoma, large-cell carcinoma or adenocarcinoma and adenosquamous carcinoma. The overall 5-yr survival is poorer in non-squamous-cell carcinoma compared with squamous cell carcinoma." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

"Non-smokers who have high risk carcinoma of the lung have good prognostic factors. Therefore, they should be considered for clinical trials. Clinicians should assess patients' comorbidities and use individualized therapy plans for the treatment of lung cancer." - Anonymous Online Contributor

Unverified Answer

How does ipilimumab work?

"In patients with advanced non-small-cell lung cancer, treatment with chemotherapy plus a checkpoint inhibitor, etoposide, and carboplatin in patients who did not have EGFR mutations did not produce improved survival rates compared with chemotherapy alone. In contrast, patients treated with the immunotherapeutic agent ipilimumab had better overall survival rates compared with chemotherapy-only-treated patients. On the basis of these data, etoposide and carboplatin should be reconsidered as first-line chemotherapy options in patients with advanced NSCLC, whereas ipilimumab may be a more effective first-line therapy." - Anonymous Online Contributor

Unverified Answer

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

"The presence of systemic spread of carcinoma NSCLC was determined by (1) biopsy of the lung only if necessary (2) negative PET scan of the chest, if there is a suspicion of carcinoma NSCLC, and (3) negative chest CT. The decision on the optimum method to determine whether systemic spread is present should be based on the risk of spread versus the possibility of not finding it on the biopsy. The decision-making process could be simplified considerably if we consider the patients with a history of limited resections or metastatic disease as those with the greatest risk of systemic spread." - Anonymous Online Contributor

Unverified Answer

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

"Serious carcinoma, non-small-cell lung is rare. The risk can be increased by several risk factors. We suggest that the development of carcinoma, non-small-cell lung in a patient with a malignancy that was already present might be serious and needs to be checked promptly." - Anonymous Online Contributor

Unverified Answer

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

"There is substantial variation across countries, with one group of European countries having a survival rate >90%, and another having a survival rate <20%. There is a significant inverse relationship between survival rate and population age, and survival rate decreases for every 5 years after the age of 60 years. There is no difference in survival rate between men and women. There are differences in the survival rate depending on the type of lung cancer, with adenocarcinoma having a survival rate 15% higher than squamous cell lung cancer." - Anonymous Online Contributor

Unverified Answer

Is ipilimumab typically used in combination with any other treatments?

"Ipilimumab was typically used in combination with a variety of other treatments in most of the trials. Clinical trials of ipilimumab were mainly focused on SCC. Only two of the clinical studies included patients with NSCLC; these studies used gemcitabine as part of their adjuvant therapy." - Anonymous Online Contributor

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