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Lung cancer drug combo study halted after just 4 patients

NCT ID NCT06516887

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if combining two drugs, bemcentinib and pacritinib, could help people with advanced lung adenocarcinoma that had stopped responding to other treatments. Only 4 patients were enrolled before the study was terminated early, so no conclusions can be drawn about safety or effectiveness. The trial was designed to measure how long patients lived without their cancer getting worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

4 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with histologically-or cytologically confirmed diagnosis of locally advanced and/or metastatic lung adenocarcinoma (Stage IV/AJCC Edition 8) (any PD-L1 status) without actionable driver mutations, who has failed at least one line of systemic treatment. Patients with locally advanced and/or metastatic lung adenocarcinoma with driver mutation who have failed standard targeted therapies can also be enrolled on this study. 2. Be refractory to, or intolerant of, an established therapy known to provide clinical benefit for their condition. Patients can be eligible for study if they have failed at least one line of treatment. 3. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator. Evaluable disease in phase 1 is allowed. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (AppendixH) 5. Life expectancy of at least 3 months 6. Be ≥18 years of age 7. Negative pregnancy test (if female of childbearing potential) 8. Adequate liver function: * Total bilirubin \<1.5x upper limit of normal (ULN) (\<3xULN for subjects with liver metastases) * Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase \<2.5 x ULN. * If liver metastases are present, then AST and ALT \<5 x ULN is allowed. 9. Adequate renal function with calculated creatinine clearance ≥30 mL/min by Cockcroft-Gault Formula. 10. Adequate hematologic status: * Absolute neutrophil count ≥1500 cells/mm3 * Platelet count ≥100,000 (plt/mm3) * Hemoglobin ≥9 g/dL 11. Have no clinically significant abnormalities on urinalysis 12. Have acceptable coagulation status: * Prothrombin time (PT) ≤ 1.5 x ULN * Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 13. Be non-fertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an highly effective method of contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 90 days after the last study drug dose. Female patients using hormonal contraceptive agent should use at least one additional non-hormonal method of contraception (e.g., IUD, condom, abstinence). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 14. Have read and signed the IRB-approved informed consent form prior to any study related procedure. If a patient is re-screened for the clinical trial or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed. 15. Patients enrolled in the Expansion Cohort must be willing to consider pre-study and on-study biopsies, if safe and medically feasible, as determined by a board-certified interventional radiologist. Four to eight core samples will be requested at each biopsy timepoint. 16. Patients must be able to swallow and tolerate oral medications. Exclusion Criteria: 1. History of the following cardiac conditions: 1. An acute ischemic cardiac event (e.g., myocardial infarction) or hospitalization for unstable angina within 3 months prior to first dose. 2. Abnormal left ventricular ejection fraction on echocardiography (less than the lower limit of normal for a subject of that age at the treating institution or Grade 2 severity according to the New York Heart Association as defined by symptoms at less than ordinary levels of activity. Echo will only be considered for symptomatic patients with heart disease and concerns for heart failure. The Echo would be ordered by PI as standard of care. 3. Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension (i.e., sustained systolic BP \>160 mmHg or diastolic BP \>90 mmHg), or need to change medication due to lack of disease control within 12 weeks prior to the provision of consent. 4. History or presence of bradycardia (≤55 bpm) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias as defined by the need for treatment. 5. Presence of any factors that increase the risk for QTc prolongation, e.g., resistant, or inadequately treated heart failure, presence of hypokalemia or hypomagnesemia not corrected by, or not responding to, replacement therapy or inadequately treated hypothyroidism as defined by the thyroid-stimulating hormone not within the expected range of the institution. 6. Family history of long QTc syndrome or ventricular arrhythmias; personal history of long QTc syndrome or previous drug induced QTc prolongation of at least Grade 3 (QTc \>500 ms). (Appendix I) 2. Have a corrected QT interval (QTcF, Fridericia's method) of \>450 msec in men and \>470 msec in women. 3. Presence of symptomatic central nervous system metastatic disease that requires local therapy such as radiotherapy, surgery, or increasing dose of steroids within 2 weeks prior to Day 1 treatment. 4. Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to Day 1 5. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 6. Are pregnant or nursing. 7. Received treatment with radiation therapy, chemotherapy, or investigational therapy within 28 days or 5 half-lives, whichever occurs first, prior to study entry. 8. Are unwilling or unable to comply with procedures required in this protocol. 9. Have known infection with human immunodeficiency virus, hepatitis B, or hepatitis C. Patients with history of chronic hepatitis that is not active are eligible. 10. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure (Child Pugh class B or C), or other conditions) that could compromise protocol objectives in the opinion of the clinical investigators. 11. Uncontrolled diarrhea (grade ≥ 2). 12. Recent bleeding (grade ≥2 within the past 3 months unless precipitated by another event (e.g., trauma, surgery). 13. Use of anticoagulant or anti-platelet agents within the prior 14 days other than baby aspirin. 14. Use of strong CYP3A4 inducers or inhibitors within 5 half-lives prior to cycle 1 day 1 treatment. Patients enrolled in PK study should not be taking a moderate/severe CYP3A4 inhibitor or inducer. 15. Are currently receiving any other investigational agent. 16. Have exhibited allergic reactions to a similar structural compound or formulation as pacritinib or bemcentinib. 17. Patients with severe lactose intolerance, hereditary galactose intolerance, LAPP-lactase deficiency and/or glucose-galactose malabsorption at the discretion of the PI\>. 18. Have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption. 19. Have a history of severe adverse reaction (e.g., hypersensitivity reaction, anaphylaxis) to sulfonamides. 20. Patients who are currently taking H2-receptor agonists (e.g., cimetidine, ranitidine) or proton pump inhibitors (e.g., omeprazole) must be able to discontinue their use at least seven days prior to the first dose of study treatment and throughout the period they are receiving study treatment. Patients who are unable to do so will be deemed ineligible. 21. Patients with retinopathy. Other ophthalmologic diseases may be allowed at the investigator's discretion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.