Caring for patients with early-stage NSCLC?

Consider the NEO-Empower study

The NEO-Empower study seeks to build upon the current standard of care (chemotherapy plus a PD-1 inhibitor) for the perioperative treatment of patients with early-stage NSCLC. Consider NEO-Empower as an opportunity for your patients with newly diagnosed resectable stage II to stage IIIB (N2) NSCLC who might benefit from investigational approaches intended to deepen pathologic responses and extend event-free survival.

NEO-Empower is a phase 2 platform study for adults with early-stage NSCLC. The study will evaluate a control treatment (consisting of chemotherapy plus an investigational PD-1 inhibitor) in comparison to several investigational treatments (consisting of chemotherapy plus an investigational PD-1 inhibitor plus a third investigational anti-cancer drug). The investigational drugs may include bispecific antibodies, checkpoint inhibitors, targeted agents, antibody drug conjugates, and other modalities that may potentially deepen the anti-tumor immune response. This trial is designed as a platform study so that multiple investigational arms can be tested during the lifecycle of the study. The primary endpoint is the major pathologic response rate assessed at surgery. Investigational arms that fail to improve pathologic response rates in comparison to the control arm will be closed for futility while newer investigational arms with potential for efficacy and an appropriate safety profile for use in the perioperative setting will be added.

Patients will be treated with neoadjuvant therapy, followed by surgery, and then adjuvant therapy. They will receive up to 3 cycles of neoadjuvant treatment with the control or investigational regimen, followed by surgery, and then up to 7 cycles of adjuvant PD-1 inhibitor immunotherapy.

The first investigational anti-cancer drug tested in the study is a bispecific antibody that binds the proteins EGFR (epidermal growth factor receptor) expressed on lung cancer cells and CD28 (cluster of differentiation 28) expressed on T-cells. This drug is intended to promote full activation of anti-tumor T-cells to generate more robust immune responses.

The duration of study participation for each participant will vary based on the response to the study drugs, disease progression/recurrence, and side effects from the study drugs. The treatment period of the study will last approximately one year. All patients will also be followed for recurrence of disease and survival.

There will be no cost for the study drugs, visits, tests, or supplies that are required for the study for qualified patients. Reasonable travel and food costs will be reimbursed.

About the NEO-Empower study

How can you help?

NEO-Empower is enrolling approximately 40 people with early-stage NSCLC into the first investigational treatment group at 50 to 75 sites worldwide. We will open other investigational treatment groups testing new drugs in the near term. The overall projected enrollment into all investigational groups and the control group will be 120 patients. The control treatment group will enroll continuously throughout the trial. The success of NEO-Empower depends on physicians who refer potential study participants. Your patients may be eligible if they:

Please note: Other protocol-defined inclusion/exclusion criteria apply.

The study team will check your patient’s full medical history to see if they meet all inclusion criteria and none of the exclusion criteria. Diversity in clinical studies is critical to developing better treatments – help ensure that your patients are represented.

If you have potentially eligible and interested patients, empower them with options and discuss NEO-Empower. You may also contact the nearest study site to refer them. Information about study sites is available on the registries listed below.

Your patient’s health and safety are our top priorities. We hope you value the impact of this research and will consider referring potential candidates. With your support, we hope to help patients with early-stage NSCLC.