Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

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.

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

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Puma Biotechnology, Inc.

• Primary ID PUMA-NER-5201
• Secondary IDs NCI-2014-00495, 2013-002872-42
• Clinicaltrials.gov ID NCT01953926