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Non-small Cell Lung CancerPhase 2NCT06522360

Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)

A Phase 2 study testing Brigatinib, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. 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, Carboplatin and Pemetrexed
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
11 Dec 2024to 17 Apr 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

  • Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
  • Documented ALK re-arrangement as detected by: (1) FISH, (2) IHC, (3) tissue NGS, or (4) cfDNA NGS
  • Subjects can be enrolled as (a) TKI naïve or (b) after/during 12 weeks of first line brigatinib treatment without disease progression or (c) after 4 weeks of first line alectinib, lorlatinib or ensartinib treatment without disease progression, those patients must be switched to brigatinib.
  • Candidate for local consolidation therapy in the opinion of the treating physician.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 6. Males or females ≥ 18 years. Because no dosing or adverse event data are currently available on the use of brigatinib in combination with other agents in patients <18 years of age, children are excluded from this study.
  • 7. Adequate organ function laboratory values, defined as:
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  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or at least 1500/mm3 or at least 1.5 x 109/L b. Platelet count at least 75,000/mm3 or at least 75 x 109/L c. Hemoglobin (Hb) at least 9 g/dL (or 5.69 mmol/L) at baseline d. Serum creatinine ≤ 1.5 × ULN or ≥ 60 mL/minute for subjects with creatinine clearance levels > 1.5 × the institutional ULN e. Serum total bilirubin less than or equal to ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 × ULN f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN except for subjects with liver metastases for whom ALT and AST should be ≤ 5× ULN g. International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants h. Activated PTT (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulant 8. Female patients of childbearing potential must have a negative pregnancy test documented at time of screening.
  • 9. Female patients who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to use a highly effective method of contraception 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 intercourse
  • The effects of brigatinib on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • 10. 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 b. Agree to completely abstain from heterosexual intercourse c. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of brigatinib administration.
  • 11. Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 milliseconds (msec) in males or ≤470 msec in females.
  • 12. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
  • 13. Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • 1. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who have had at least 2 years elapsed since the completion of radical treatment and the adjuvant therapy, if any, of the other primary malignancy.
  • 2. Previously received any prior TKI, including ALK-targeted TKIs. Note: on-going first line brigatinib, alectinib, lorlatinib and ensartinibuse as specified in the Inclusion criteria is allowed.
  • 3. Previously received more than 1 cycle of chemotherapy +/-immunotherapy for locally advanced or metastatic disease.
  • 4. Symptomatic CNS metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted.
  • 5. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
  • 6. The presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis at screening.
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  • 7. Have a known or suspected hypersensitivity to brigatinib or its excipients. 8. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition that could affect oral absorption of the study drug.
  • 9. Have uncontrolled hypertension. Patients with hypertension as defined by current standard of practice should be under treatment on study entry to control blood pressure.
  • 10. Received radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
  • 11. Had major surgery within 30 days of enrollment. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
  • 12. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following: a) Myocardial infarction within 6 months before enrollment. b) Unstable angina within 6 months before enrollment. c) New York Heart Association Class III or IV heart failure within 6 months before enrollment. d) History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician. e) Any history of clinically significant ventricular arrhythmia.
  • 13. Had a cerebrovascular accident within 6 months before first dose of study drug.
  • 14. Have an ongoing or active infection, including the requirement for intravenous antibiotics.
  • 15. Subjects should not receive other anti-cancer agents (e.g., chemotherapy, immunotherapy, biologic therapy, and/or hormone therapy other than for replacement or appetite stimulant) while on treatment in this study.
  • 16. History of allergic reactions attributed to compounds of similar chemical or biologic composition to brigatinib, carboplatin and pemetrexedor other agents used in study.
  • 17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.
  • 18. Pregnant women are excluded from this study because brigatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with brigatinib, breastfeeding should be discontinued if the mother is treated with brigatinib. These potential risks may also apply to other agents used in this study.

About this study

The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.

Read the detailed description

To compare the 2-year PFS rate of ALK+ NSCLC patients treated with brigatinib to those treated with brigatinib and local consolidation therapy (LCT).

To compare the 2-year PFS rate of ALK+ NSCLC patients treated with brigatinib to those treated with brigatinib and chemotherapy.

To assess the safety and tolerability of brigatinib and LCT. To assess the safety and tolerability of brigatinib and chemotherapy.

To increase trial enrollment in underserved population.

To determine overall survival (OS) in patients treated with single agent brigatinib, brigatinib plus LCT and brigatinib plus chemotherapy.

To assess the time to progression of non-LCT lesions in the brigatinib plus LCT arm.

Being tested
Brigatinib, Carboplatin, Pemetrexed
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.

Study groups in NCT06522360
Study groupRoleWhat they receive
Brigatinib MonotherapyExperimentalGiven by mouth
Receives: Drug: Brigatinib
Brigatinib + Carboplatin + PemetrexedExperimentalGiven by vein
Receives: Drug: Brigatinib; Drug: Carboplatin; Drug: Pemetrexed
Brigatinib + Local Consolidation Therapy (LCT)ExperimentalGiven by vein
Receives: Drug: Brigatinib

What is being measured

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

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted26 Jul 2024
  2. Study start11 Dec 2024
  3. Primary completion17 Apr 2025
  4. Study completion17 Apr 2025

Why it stopped: 0 participants enrolled

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522360
Sponsor's protocol ID
2024-0130
Other IDs
NCI-2024-06173
Status last verified
Apr 2025
First submitted
22 Jul 2024
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brigatinib, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center.

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 22 inclusion and 17 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: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year). 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 NCT06522360.

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 24 Apr 2025.

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