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LCRF/Bayer Research Award on Innovative Therapeutic Strategies to Treat Lung Cancers Harboring HER2 Mutations and/or Other HER2 Alterations

Lung Cancer Research Foundation

Lung cancer is responsible for more deaths worldwide than any other cancer accounting for an estimated 125,070 deaths annually in the United States alone.1 The last 10-15 years have seen accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma (NSCLC) in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers.

The HER family of tyrosine kinases include HER1 (epidermal growth factor receptor [EGFR] or ERBB1), HER2 (HER2/neu or ERBB2), HER3, and HER4. EGFR mutations were one of the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibit ors. Despite substantial progress in this area, available treatments are generally not curative, and resistance invariably develops. 20 years ago, HER2 mutations have also been identified as potential oncogenic drivers in lung cancer. 2,3 HER2 does not have an endogenous ligand but rather heterodimerizes with other HER family receptors and activates downstream signaling through the PI3K/AKT and RAS/MAP/MEK pathways. HER2 mutations occur in up to 4% of NSCLC. In the past two decades, several clinical trials have investigated the use of anti-HER2 therapies in lung cancer but led to disappointing results. On August 11, 2022, the Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. 4 This is a small but positive step forward for patients with NSCLC whose tumors harbor these mutations.

Immunotherapeutic strategies have not been successful in the treatment of lung cancers with EGFR or HER2 mutations. It is of vital importance that there is a better understanding of the mechanism of tumor response and resistance. Moreover, given that therapeutic options available to date are not curative, there is a need for novel approaches to treat HER2-mutant lung cancers. This grant mechanism will focus on the science behind HER2 alterations as oncogenic drivers of malignancy and/or the development of novel therapeutic approaches for patients with tumors harboring HER2 mutations and/or other HER2 alterations.

Work supported through this mechanism will address important mechanistic questions and developmental therapeutics across the care continuum and have the potential to increase survivorship. Given the specific interest in the development of novel therapies for this group of patients, it is preferred that a clinical trial be associated with or planned as a result of the findings of the project. It is also expected that a program of correlative, translational research will be proposed that will enhance the understanding of these oncogenic-driven lung cancers.

We encourage applications on a wide variety of topics related to HER2 alterations and lung cancer, including but not limited to the following:

• The proposal must be associated with a clinical trial, either ongoing or planned as a result of the project. The trial can investigate novel treatment approaches, new therapies (i.e. next generation drugs or agents with novel mechanisms of action), and novel combinations. Therapy can include targeted agents (TKIs), antibody-drug conjugates, immunotherapies, cell therapies etc. if there is a reasonably strong rationale supporting the investigation.

• The proposal must have a program of basic and/or translational work associated with the clinical trial. Topics of interest can include but are not limited to mechanisms of primary or secondary resistance, studies on the immune landscape and tumor microenvironment, biology and mechanisms of tumor progression, identification of biomarkers to predict sensitivity to specific therapies, methods for optimizing treatment (efficacy and/or tolerability), etc.

• The proposal must include studies in patients with lung cancer harboring HER2- mutations and /or other HER2 alterations.

• A patient/patient advocate needs to be part of the research team applying for the grant and that this individual should have a role in the design of the research.

2. Budget Requirements

• The maximum award amount is $500,000 for a period of two years ($250,0000 per year). Additional budget requirements and considerations include the following:

• The LCRF grant must be the primary source of research support for the proposal. Since a clinical trial is associated with the project, it is suggested that additional funding be obtained from a funding partner to support the clinical trial costs. Additional secondary funding (e.g. for core services support) is also permitted.

• Up to 50% of the grant (i.e. $250,000 over 2 years) should be allocated to support the scientific translational work associated with the proposal.

• There is no limit on the amount of salary support that may be requested. However, appropriate justification for all budget items is required. Any salary requests more than 20% of the total budget must be explicitly justified.

• Any equipment costs must be limited and directly applicable to the research project (i.e. large, general equipment costs are not permitted).

• Direct patient care costs reimbursable by other sources may not be included.

• Travel and publication costs are permitted.

• Up to 10% of the funding from this award may be used to support institutional indirect / facilities and administrative costs.

Specialties

Cancer

Clinical Trials

Molecular Biology

Others

Pulmonology

Cell Biology

Immunology

Oncology

Pathology

Eligibility Requirements

Investigators must be affiliated with a non-profit, academic or research institution. An applicant must have a postdoctoral or clinical research fellow appointment and/or a faculty position and may have any level of research experience. Applicants from US-based and international institutions are eligible to apply and may hold any residency/citizenship status. Applicants are prohibited from applying in more than one of LCRF’s funding tracks in the same cycle. Any questions regarding eligibility should be directed to the LCRF Grants Office before the submission of an application.

Sponsor Details

Sponsor Institute/Organizations: Lung Cancer Research Foundation

Address: 501 7th Avenue, Suite 401 New York, NY 10018 United States

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