What is neratinib studying for HER2 positive solid tumors?

Neratinib is being studied alone and in combination with palbociclib to evaluate their effects on controlling HER2 positive solid tumors. This trial aims to understand if adding palbociclib improves disease control and survival. The National Cancer Institute is leading this study to explore these targeted treatments.

Who may be eligible for this HER2 positive solid tumor clinical trial?

Adults 18 years or older with recurrent or persistent HER2 amplified solid tumors, excluding breast cancer, may be eligible. Participants must not be pregnant or nursing and should not have prior treatment with HER2 tyrosine kinase inhibitors or CDK4/6 inhibitors. Please review eligibility criteria for more details.

Is there any cost to participate in this HER2 positive solid tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect regular visits and monitoring during the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06126276

Study of Neratinib Alone or Combined With Palbociclib for Treating HER2-Positive Gynecologic and Other Solid Tumors in Adults

Led by National Cancer Institute (NCI) · Updated on 2026-08-06

Participants Needed

189

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of neratinib alone compared to a combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors, including gynecologic cancers. This phase II trial seeks to determine which treatment better controls disease progression and improves survival. The study also explores how specific tumor and blood markers relate to treatment response and resistance. Participants are randomly assigned to one of two treatment groups. One group receives neratinib orally once daily in repeated 28-day cycles, with an initial 14-day dosing period followed by continuous dosing. The other group receives the same neratinib schedule combined with palbociclib taken orally for 21 days each cycle. Patients undergo heart function tests, imaging scans like CT or MRI, blood sample collections, and tumor biopsies during screening and throughout the trial. Patients whose disease progresses on neratinib alone may switch to the combination treatment. During the study, participants have regular assessments including echocardiograms or MUGA scans, CT or MRI scans, and blood draws to monitor treatment effects and safety. Tumor biopsies may be performed before and during treatment. After completing study treatment, patients are followed every three months for two years to track progression-free survival and overall survival. The main outcome measured is the time from study entry until disease progression or death, assessed for up to two years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient must be enrolled in EAY191 and assigned to ComboMATCH EAY191-N5 based on an actionable mutation
Have a HER2 amplified solid tumor excluding breast cancer
HER2 status confirmed by immunohistochemistry (IHC) or in situ hybridization (ISH)/fluorescence in situ hybridization (FISH) or next generation sequencing (NGS) as specified
Recurrent or persistent disease
No known RB1 loss or deletion
Disease must be safely biopsiable or archival tissue available within 12 months
Measurable disease with at least two measurable lesions
Treated brain metastases allowed if stable and asymptomatic for 3 months without steroids
No leptomeningeal disease
Up to 5 prior lines of systemic therapy allowed
Prior trastuzumab, pertuzumab, or antibody drug conjugates allowed
No prior HER2 tyrosine kinase inhibitor or CDK4/6 inhibitor therapy
No cancer therapy within 3 weeks prior to registration (oral therapy washout per drug half-life)
Age 18 or older
ECOG performance status of 0, 1, or 2
Not pregnant or nursing
Adequate blood counts and organ function as specified
Cardiac function class 2B or better
No active infection requiring IV antibiotics
No current abdominal abscess, fistula, GI perforation, obstruction, or need for feeding tubes
No significant gastrointestinal disease causing moderate to severe diarrhea or inability to tolerate oral therapy
No lung disease causing dyspnea at rest
No active interstitial lung disease
No history of allergic reaction to study agents or related compounds

You will not qualify if you...

IHC score 0 or 1+ for HER2 regardless of other tests
Negative ISH/FISH and NGS when IHC is 2+
Evidence of RB1 loss or deletion
Disease not safely biopsiable and no archival tissue within 12 months
Untreated or progressing brain metastases
Leptomeningeal disease
More than 5 prior lines of systemic therapy
Prior therapy with HER2 tyrosine kinase inhibitors or CDK4/6 inhibitors
Cancer therapy within 3 weeks prior to registration (exceptions per drug half-life)
Pregnant or nursing women
Poor performance status (ECOG >2)
Blood counts or organ function below required thresholds
Cardiac function worse than class 2B
Active infection requiring parenteral antibiotics
Current abdominal or gastrointestinal complications as specified
Severe gastrointestinal disease affecting oral therapy
Lung disease causing dyspnea at rest
Active interstitial lung disease
Allergic reactions to study drugs or related compounds

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Study of Neratinib Alone or Combined With Palbociclib for Treating HER2-Positive Gynecologic and Other Solid Tumors in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria