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Non Small Cell Lung CancerPhase 2NCT04074993

Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays

A Phase 2 study testing Brigatinib in people with Non Small Cell Lung Cancer, run by JI-YOUN HAN at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is single-arm, open-label study design. Patients will receive brigatinib until disease progression, unacceptable toxicity, withdrawal of consent, of death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Brigatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSouth Korea
Study dates
15 May 2020to 31 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant(or legally acceptable representative if applicable) provides written informed consent for the study
  • Patients who have disease progression with prior one ALK-TKI treatment for inoperable Stage III (locally advanced) or metastatic ALK+ NSCLC.(Previous treatment only allowed one ALK-inhibitor) Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle.
  • ALK rearrangement , as detected via the blood somatic mutation assay
  • One prior ALK inhibitor therapy
  • Have at least 1 measurable lesion per RECIST version 1.1
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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  • Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, version 5.0, Grade≤1(Note : Alopecia, sensory neuropathy Grade≤2, or other Grade≤2 AEs not constituting a safety risk based on Investigator's judgement are acceptable
  • Have a life expectancy of ≥3 months
  • Have adequate organ and hematologic function as determined by:
  • ALT/AST≤2.5×ULN; ≤5×ULN is acceptable if liver metastases are present
  • Total serum bilirubin≤1.5×ULN (<3.0×ULN for patients with Gilbert syndrome)
  • Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, using the MDRD equation
  • Absolute neutrophil count ≥1.5×109/L.
  • Platelet count ≥75×109/L.
  • Hemoglobin ≥9 g/dL.
  • Serum lipase ≤1.5×ULN
  • For female patients of childbearing potential, have a negative pregnancy test(urine or serum) documented ≤3 days before start of study medication.
  • non-childbearing potential which is defined as :
  • female patient≥45 years of age and has not had menses for greater than 1 year
  • a female who is status post hysterectomy, oophorectomy
  • Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourseHave the willingness and ability to comply with scheduled visit and study procedures.
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
  • Agree to completely abstain from heterosexual intercourse
  • Have the willingness and ability to comply with scheduled visit and study procedures.
  • Be ≥ 18 years of age

Who cannot join

  • Has received ALK-targeted TKI within 7 days before the first dose of study treatment(If clinically justified, 3 days wash-out period could be allowed).
  • Has received radiotherapy within 14 days before the first dose of study treatment except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A 1-week washout is permitted for palliative radiation(≤2 weeks of radiotherapy) to non-CNS disease.
  • Had major surgery within 28 days of the first dose of study treatment. Minor surgical procedures are allowed.
  • Has symptomatic brain metastasis or leptomeningeal disease. Prior brain metastasis or leptomeningeal disease allowed if asymptomatic or stable symptoms that did not require an increased dose of corticosteroids to control symptoms within 7 days prior to study enrollment. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or stereotactic radiosurgery treatment before enrollment and be clinically stable.
  • Has current spinal cord compression
  • Other malignancy within 3 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
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  • Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
  • Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
  • Myocardial infarction within 6 months before the first dose of brigatinib.
  • Unstable angina within 6 months before first dose of brigatinib.
  • Congestive heart failure within 6 months before first dose of brigatinib.
  • History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia).
  • Any history of clinically significant ventricular arrhythmia.
  • Has uncontrolled hypertension.
  • Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose brigatinib.
  • Have a history or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation-related pneumonitis
  • Active infection requiring systemic therapy.
  • Known history of HIV infection.
  • Has a known or suspected hypersensitivity to brigatinib or its excipients.
  • Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug (if applicable).
  • Have any condition or illness that, in the opinion of the investigator, would compromise
  • patient safety or interfere with the evaluation of brigatinib
  • Received systemic treatment with strong cytochrome P-450 (CYP)3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before enrollment.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

Other trials in South Korea

About this study

This is single-arm, open-label study design. Patients will receive brigatinib until disease progression, unacceptable toxicity, withdrawal of consent, of death.

Read the detailed description

Based on the clinical efficacy of ALK inhibitors in ALK+NSCLC, NCCN guidelines recommend ALK molecular testing of lung cancer patients, to select patients for ALK-targeted therapy. However, molecular testing via tissue biopsy cannot always be performed on NSCLC patients, potentially limiting access of effective treatment to the subset of patients who are able to undergo current testing procedures that utilize tissue biopsies. Obtaining an adequate tissue biopsy specimen for NSCLC presents a number of challenges. In particular, the method for diagnosis of lung cancer depends on the location, size, and type of suspected lung cancer, and the presence or absence of metastases. Common procedures for centrally located tumors include bronchoscopy and sputum cytology, which frequently yield insufficient tumor tissue for comprehensive mutation testing. In addition, 75% of patients are diagnosed with late-stage disease and often present with multiple comorbidities. Biopsies in these patients can lead to complications such as pneumothorax, hemoptysis, other bleeding complications, and cardiopulmonary decompensation. As a result of these factors, a physician treating a patient who presents with a significant burden of disease as well as significant comorbidities may rightly consider whether it is in the best interest of the patient to undergo a risky and potentially unsuccessful procedure. Thus, there exists a major unmet clinical need for testing procedures that do not require tumor tissue. The purpose of this phase II study is to assess the efficacy of brigatinib in patients with advanced NSCLC harboring ALK rearrangement that are selected using predictive biomarkers identified via blood-based assays.

Being tested
Brigatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrigatinibDrug

    Subject will be treated with Brigatinib 90mg/day for 1 week and then 180mg/day PO daily. A Cycle will be defined as 28-days. Treatment will be continued until disease progression or unacceptable toxicity.

Study groups in NCT04074993
Study groupRoleWhat they receive
BrigatinibExperimentalSubject will be treated with Brigatinib 90mg/day for 1 week and then 180mg/day PO daily. A Cycle will be defined as 28-days. Treatment will be continued until disease progression or unacceptable toxicity.
Receives: Drug: Brigatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Objective response rate

    Measured: From Cycle1 Day 1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. Tumor assessment will be performed at the end of cycle 2(every 2 cycles, each cycle is 28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start15 May 2020
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074993
Sponsor's protocol ID
NCC2019-0212
Status last verified
Sep 2023
First submitted
25 Aug 2019
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brigatinib in people with Non Small Cell Lung Cancer, run by JI-YOUN HAN at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From Cycle1 Day 1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. Tumor assessment will be performed at the end of cycle 2(every 2 cycles, each cycle is 28 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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