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New treatment option for Lung Cancer
Official title Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
ClinicalTrials.gov ID: NCT05987644
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General Subject must meet all of the following applicable to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be...
- Age ≥ 18 years at the time of consent.
- Fluent English skills with comprehensive/speaking skills equal to those of a native English speaker as assessed by the site investigator.
- ECOG Performance Status of ≤ 2 within 14 days prior to registration.
You likely can't join if
- people meeting any of the criteria below may not participate in the study:
- Active infection requiring systemic therapy.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- Treatment with any investigational drug within 28 days prior to registration.
See the full eligibility criteria
- General Subject must meet all of the following applicable to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Fluent English skills with comprehensive/speaking skills equal to those of a native English speaker as assessed by the site investigator.
- ECOG Performance Status of ≤ 2 within 14 days prior to registration.
- Histological or cytological confirmation of Stage IV (per AJCC 8th edition) non-small cell lung cancer (NSCLC).
- At least one intracranial metastasis on MRI imaging.
- Confirmation of positive ALK rearrangement per local standard of care testing.
- All people must have brain metastases and be either asymptomatic or minimally symptomatic per investigator discretion without plan for surgical intervention within 28 days of study start. Patients with neurological...
- people must be planning on therapy with alectinib. Alectinib may have been started up to 8 weeks prior to registration.
- Prior non-ALK directed therapy for metastatic disease is permitted. Patients who have received prior neoadjuvant or adjuvant chemotherapy, radiotherapy, immunotherapy (PD-1 or PD-L1 monoclonal antibodies) or...
- Documentation of consultation with a radiation oncologist confirming review and approval of the radiation therapy plan as outlined in Section 5.
- Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration.
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. See protocol for definition of childbearing potential.
- Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in the protocol.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
- Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- people meeting any of the criteria below may not participate in the study:
- Active infection requiring systemic therapy.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen, per treating physician...
- Treatment with any investigational drug within 28 days prior to registration.
- Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Aurora, Colorado, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Aurora, Colorado, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.