A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    May 7, 2024
  • participants needed
    246
  • sponsor
    Takeda
Send
Updated on 24 February 2021
See if I qualify

Summary

Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib.

At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance:

  • Brigatinib tablets
  • Alectinib capsules

All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped.

After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

Description

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK+ NSCLC.

The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA).

The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

  • Brigatinib
  • Alectinib

All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study.

This multi-center trial will be conducted in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Details
Condition ALK-positive Advanced NSCLC, ALK-positive Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC, ALK+ Advanced NSCLC
Treatment Alectinib, brigatinib
Clinical Study IdentifierNCT03596866
SponsorTakeda
Last Modified on24 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: ALK-positive Advanced NSCLC or ALK+ Advanced NSCLC?
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC
Must meet one of the following criteria
Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx
Have documented ALK rearrangement by a different test and be able to provide tumor sample to the central laboratory. (Note: central laboratory ALK rearrangement testing results are not required to be obtained before randomization)
Had PD while on crizotinib, as assessed by the investigator or treating physician. (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy)
Treatment with crizotinib for at least 4 weeks before progression
Have had no other ALK inhibitor other than crizotinib
Have had no more than 2 prior regimens of systemic anticancer therapy (other than crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer therapy regimen will be counted if it is administered for at least 1 complete cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if disease progression/recurrence occurred within 12 months upon completion of this neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy will be considered as one regimen if the maintenance therapy consists of a drug or drugs that were used in the regimen that immediately preceded maintenance)
Have at least 1 measurable (that is, target) lesion per RECIST v1.1
Have recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE) v4.03 grade less than or equal to (<=)1. (Note: treatment-related alopecia or peripheral neuropathy that are grade greater than (>) 1 are allowed, if deemed irreversible)
Have adequate organ function, as determined by
Total bilirubin <=1.5 times the upper limit of normal (ULN)
Estimated glomerular filtration rate greater than equal to (>=) 30 milliliter per minute (mL/min)/1.73 square meter [m^2], using the modification of diet in renal disease equation
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <=2.5 _ULN; <=5_ULN is acceptable if liver metastases are present
Serum lipase <=1.5ULN
Platelet count >=7510^9 per liter [/L]
Hemoglobin >=9 gram per deciliter (g/dL)
Absolute neutrophil count >=1.510^9 / L
Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests)

Exclusion Criteria

Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L)
Had received crizotinib within 7 days before randomization
Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis
Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry
Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before randomization
Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization
Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
Had received antineoplastic monoclonal antibodies within 30 days of randomization
Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy
Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed
Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening (participants with asymptomatic brain metastases or participants who have stable symptoms and did not require an increased dose of corticosteroids to control symptoms within 7 days before randomization will be enrolled). Note: If a participant has worsening neurological symptoms or signs due to CNS metastasis, the participant needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants) for 7 days before randomization
Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed
Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following
Myocardial infarction within 6 months before randomization
Unstable angina within 6 months before randomization
New York Heart Association Class III or IV heart failure within 6 months before randomization
History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician
Any history of clinically significant ventricular arrhythmia
Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug
Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug
Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics
Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history
Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients
Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history
Life-threatening illness unrelated to cancer
Any serious medical condition or psychiatric illness that could, in the investigator's opinion, potentially compromise patient safety or interfere with the completion of treatment according to this protocol
Female patients who are lactating and breastfeeding
Admission or evidence of illicit drug use, drug abuse, or alcohol abuse
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note