Phase 2 Lung Cancer Trial, Recruiting NCT05987644 Sponsor: Joshua Palmer Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05987644
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older at the time of giving consent.
  • People who are fluent English speakers, with reading and speaking skills assessed by the site investigator as being at a native speaker level.
  • People with a general health and activity level rated as reasonably functional, assessed within 14 days before joining (confirm with trial site for specific rating scale used).
  • People who have been diagnosed with Stage IV non-small cell lung cancer (a specific type and stage of lung cancer), confirmed through laboratory tissue or cell testing.
  • People who have at least one cancer lesion in the brain, confirmed by MRI scan.
  • People whose cancer has tested positive for a specific genetic change called an ALK rearrangement, confirmed through standard local testing.
  • People who have brain cancer lesions that are either causing no symptoms or only mild symptoms, and for whom surgery on the brain is not planned within 28 days of starting the study. People whose neurological symptoms are managed with steroid or anti-seizure medications may also be eligible.
  • People who have a specific type of cancer spread involving the lining of the brain and spinal cord (leptomeningeal disease) but have no symptoms from it may be eligible, provided all other criteria are also met.
  • People who are planning to be treated with a drug called alectinib. This drug may have already been started up to 8 weeks before joining the trial.
  • People who have previously received certain cancer treatments (such as chemotherapy, radiation, immunotherapy, or a combination) for non-metastatic disease, as long as at least 3 months have passed since the last treatment cycle before joining the trial.
  • People who have had a consultation with a radiation specialist who has reviewed and approved the radiation treatment plan for the study.
  • People whose blood test results show that major organs such as the liver and kidneys are working adequately, tested within 14 days before joining.
  • Women who could potentially become pregnant must have a negative blood pregnancy test within 14 days before joining.
  • Women who could potentially become pregnant, and men, must be willing to either avoid heterosexual intercourse or use effective contraception throughout the study, as outlined in the study protocol.
  • People living with HIV who are on effective treatment and have had an undetectable level of the virus in their blood within the 6 months before joining.
  • People with a long-term hepatitis B infection must have an undetectable viral level while on appropriate treatment. People with a history of hepatitis C must have completed treatment and been cured, or if currently being treated for hepatitis C, must have an undetectable viral level.
  • People who are able to understand and follow the study procedures for the full length of the study, as determined by the enrolling doctor.

Who may not be able to join:

  • People who currently have an active infection that requires treatment with systemic (whole-body) medication.
  • People who have a condition that affects the body's ability to absorb medication taken by mouth.
  • People who are currently pregnant or breastfeeding.
  • People who have had, or currently have, another type of cancer whose history or treatment could affect the safety or effectiveness of this trial, as determined by the treating doctor.
  • People who have taken part in another clinical trial involving an experimental drug within 28 days before joining.
  • People who currently have an acute (sudden or active) form of hepatitis, including viral, autoimmune, alcohol-related, or other types.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Joshua D Palmer, MD, The Ohio State University Comprehensive Cancer Center

Phone: 614-293-0871

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Joshua Palmer
Registry
ClinicalTrials.gov
Start date
7 March 2024
Est. completion
28 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases; Phase 1b: Safety and Feasibility

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov