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Testing Neratinib or Neratinib and Palbociclib for HER2+ Solid Tumors

This study is testing two treatments, neratinib alone or neratinib combined with palbociclib, for people with solid tumors that have a specific marker called HER2. These treatments are kinase inhibitors, which means they work by blocking signals that help cancer cells grow. The goal is to see if neratinib and palbociclib together can shrink or stabilize HER2-positive cancers better than neratinib alone. You might be able to join if you have a HER2-positive solid tumor (not breast cancer) and have already been assigned to this study through another trial (EAY191). Researchers will measure how long you live without your cancer growing (progression-free survival) for up to two years to see how well the treatments work.

Study design
This study plans to enroll 70 participants and compares two treatment groups: neratinib alone versus neratinib plus palbociclib.
What's involved
You would undergo a tumor biopsy, blood draws, CT scans, echocardiograms (ECHO), and MRI scans. The duration of these procedures is not specified.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be assessed for up to two years from study entry.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06126276

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~70 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyEchocardiography TestMagnetic Resonance ImagingMultigated Acquisition Scan

At a glance

Recruiting sites
183 of 194 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years

Conditions

Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm

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NCT06126276

Where you'd take part

This study runs at 194 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alaska Women's Cancer Care

    Anchorage, Alaskastudy coordinator listed

    Recruiting

  • Annie Penn Memorial Hospital

    Reidsville, North Carolinastudy coordinator listed

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvaniastudy coordinator listed

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohiostudy coordinator listed

    Recruiting

  • Ballad Health Cancer Care - Bristol

    Bristol, Virginiastudy coordinator listed

    Recruiting

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennesseestudy coordinator listed

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montanastudy coordinator listed

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montanastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Haider S Mahdi · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
Email the study team

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Eligibility criteria

Inclusion

Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
Patients must have a HER2 amplified solid tumor except breast cancer.
If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status
If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status
If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE
If IHC is unknown and…
ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE
ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE
Patients must have recurrent or persistent disease
No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
No known leptomeningeal disease
Patients may have received up to 5 prior lines of systemic therapy
Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib
No prior therapy with CDK4/6 inhibition
No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Not pregnant and not nursing
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
No active infection requiring parenteral antibiotics
No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
No lung disease causing dyspnea at rest
No interstitial lung disease with ongoing signs and symptoms at the time of registration
No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients

What this trial measures

  • Progression free survivalFrom study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years

    The stratified log-rank statistic will be used to draw inferences about the relative activity of the two regimens. Characterized by medians and Kaplan-Meier (KM) curves.