Brigatinib for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Lung Cancer+11 More
Brigatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether brigatinib and binimetinib may be effective in treating non-small cell lung cancer.

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Eligible Conditions

  • Lung Cancer
  • ALK Gene Rearrangement
  • Stage IVB Lung Cancer
  • Stage IVA Lung Cancer
  • Progressive Disease
  • Stage IIIB Lung Cancer
  • Lung carcinoma cell type unspecified stage IV
  • ROS1 Gene Rearrangement
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Stage IIIC Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lung Cancer

Study Objectives

This trial is evaluating whether Brigatinib will improve 9 primary outcomes and 5 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of Up to 28 days.

Day 1
Area Under the Plasma Concentration versus Time Curve (AUC) of Brigatinib
Year 1
Median Depth of Response Assessed by RECIST v1.1
Number of Grade 3 or Greater Treatment-Emergent Adverse Events by CTCAE v5.0
Number of Serious Treatment-Emergent Adverse Events by CTCAE v5.0
Number of Total Treatment-Emergent Adverse Events (AEs)
Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment
Number of Treatment-Emergent Adverse Events Resulting in Interruption, Reduction, or Delay of study treatment
Number of Treatment-Emergent Adverse Events by Grade
Number of Treatment-Emergent Adverse Events with an Outcome of Death by CTCAE v5.0
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 12 months
Median Overall Survival (OS)
Recommended Phase 2 Dose
Up to 28 days
Number of Participants with Dose Limiting Toxicities
Up to 6 months
Median Progression Free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Lung Cancer

Trial Design

1 Treatment Group

Treatment (brigatinib, binimetinib)
1 of 1
Experimental Treatment

This trial requires 18 total participants across 1 different treatment group

This trial involves a single treatment. Brigatinib 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.

Treatment (brigatinib, binimetinib)Patients receive brigatinib PO QD and binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
FDA approved
Binimetinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from treatment initiation through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from treatment initiation through study completion, an average of 1 year for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lung Cancer or one of the other 11 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, with no prior chemotherapy for advanced disease, and no evidence of brain metastases People with stage IIIB/IV NSCLC that have not had chemotherapy before and no brain metastases are eligible to participate. show original
) A test to look for a certain type of gene mutation, called an ALK-rearrangement (or ROS1- rearrangement), is done on a tumor sample or on cell-free DNA in a CLIA-approved laboratory show original
The text states that someone who has had a tyrosine kinase inhibitor (TKI) to treat a cancer such as ALK or ROS1 should consider trying a different TKI if their cancer progresses or they can't tolerate their current treatment. show original
the Eligibility Criteria section, the ADCS-ADL (r) item score must be below 14 at the time of the Screening Visit to be eligible for the Dose Expansion Phase show original
Please continue reading only if you have previously taken an ALK or ROS1 targeted TKI and experienced progression or intolerance on your most recent treatment. show original

Patient Q&A Section

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

"Chemotherapy is one of the oldest and most effective treatments of the above cancers. The chemotherapy agents used depend on the specifics of the malignancy, but alkylating agents are often an option. Surgical resection is frequently recommended. Radiation therapy is used commonly in curative situations and is used also to boost the efficacy of other treatments, like chemotherapy or surgery. The use of hormone therapy in treatment of all the above cancers is highly debatable." - Anonymous Online Contributor

Unverified Answer

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

"About 12,500 individuals are diagnosed with lung cancer a year in the United States. More than 90% of lung cancers are due to tobacco exposure." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"Mutations during lung development can lead to the development of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) later in life. Furthermore, cancer may develop by a gradual, slow accumulation of tiny changes in the DNA sequences associated with cancer development and progression. This accumulation of mutations is possibly due to a large number of 'driver' mutations, which are responsible for triggering cancer formation." - Anonymous Online Contributor

Unverified Answer

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

"The most common presentations of lung cancer are coughing up blood. Other possible presentations include: a persistent fast-spreading rash; hoarseness; a persistent cough with blood or sputum; weight loss; a persistent cough with purulent sputum; and a persistent cough with a change in color of the sputum after coughing. The symptoms of lung carcinoma can be found in an orderly and predictable presentation. Therefore, it is important to have high suspicion for lung cancer when patients present with cough or hoarseness." - Anonymous Online Contributor

Unverified Answer

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

"A substantial number of patients with lung carcinoma had a favorable outcome under optimal treatment. Survival after lung carcinoma resection was significantly higher than observed in current retrospective studies. This raises the question of whether, in addition to chemotherapy, adjuvant treatment is necessary to improve survival in early-stage lung carcinoma." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"Carcinoma, non-small-Cell Lung is a very aggressive tumor. It is a disease that requires a high degree of diagnosis and treatment. The initial histology is significant in determining what methods of therapy will work best. The current clinical trials that use targeted treatments or agents (e.g. Immuno-oncology) will also determine the best approach. Clinical trials have not progressed to the point where a cure exists for this disease. Patients diagnosed with this type of cancer will need to be closely monitored to determine the best options for this disease. For more patient information about carcinoma, non-small-cell lung send us a note to [power." - Anonymous Online Contributor

Unverified Answer

What is brigatinib?

"Brigatinib treatment decreases the tumor size of pre-clinical hepatocellular carcinoma models. Moreover, brigatinib treatment is associated with regression of pre-existing advanced pre-clinical lung fibrosis. Findings from a recent study demonstrate that brigatinib may be an effective treatment for patients with HCC and advanced lung fibrosis. http://www.wustl.edu/krauss/courses/courses_archive/CE/F_lectures.zip file\n\n1. Is the person on insulin therapy the same as me?\n\n2. Can I use the insulin pump?\n\n3." - Anonymous Online Contributor

Unverified Answer

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

"The majority of patients (80.0%) and caregivers were satisfied with brigatinib in terms of HRQOL, and no clinically significant changes in QOL were identified between the placebo and brigatinib groups." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, non-small-cell lung run in families?

"The present study has not replicated a previous report of a high prevalence of lung cancer among NSCLC in families. This may be due to several reasons. First, the earlier study may have been underpowered to detect small mutations of the tumor suppressor gene. Second, if this mutation had been detected, it did not affect carrier status. Third, a different mechanism of lung carcinogenesis may exist in this region." - Anonymous Online Contributor

Unverified Answer

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

"The age at diagnosis may reflect a delay in treatment if these are diagnosed late stage. It may additionally reflect an effect of smoking which is a risk factor for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). Future studies should address the question of whether screening, awareness, intervention and treatment with adjuvant treatment are indicated for all patients at diagnosis but especially in middle-aged patients where cancer remains a major cause of death." - Anonymous Online Contributor

Unverified Answer

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

"While there are not many published studies on trials for NSCLC in people on systemic chemotherapy, a recent review of 5 randomized trials found that there was significant benefit to some therapies for chemotherapy induced nausea and vomiting, which is often a very serious issue for these patients. These trials also found significant benefit in pain and fatigue. The authors concluded, 'We are encouraged by the significant improvements in clinical outcomes that have been noted on meta.analysis and by the large number of patients enrolled across randomized trials." - Anonymous Online Contributor

Unverified Answer

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

"It is clear that the current therapeutic advances in treating non-small-cell lung cancer are still incomplete. In order to better understand the clinical treatment of NSCLC, it is necessary to develop more effective drugs to be selected." - 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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