Suspended

SUMMITAn Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

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What is being tested

Neratinib

+ Fulvestrant

+ Paclitaxel

Drug
Who is being recruted

Bronchial Neoplasms+11

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorPuma Biotechnology, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2013

Actual date on which the first participant was enrolled.

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.

Official TitleAn Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
NCT01953926
Principal SponsorPuma Biotechnology, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

582 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic Neoplasms

Criteria

Inclusion Criteria: * Provide written informed consent * Histologically confirmed cancers for which no curative therapy exists * Documented HER2 or EGFR exon 18 mutation * Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol * At least one measurable lesion, defined by RECIST v1.1 Exclusion Criteria: * Participants harboring ineligible somatic HER2 mutations * Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible * Participants who are receiving any other anticancer agents * Symptomatic or unstable brain metastases * Women who are pregnant or breast-feeding There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.

Group II

Experimental
Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.

Group III

Experimental
Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers. Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.

Group IV

Experimental
Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations. Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.

Group 5

Experimental
Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.

Group 6

Experimental
Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 60 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
Suspended

Mayo Clinic Arizona

Phoenix, United States
Suspended

City of Hope

Duarte, United States
Suspended

University of California, San Diego

La Jolla, United States
Suspended60 Study Centers