Study of Eftilagimod Alfa (Efti) in combination with pembrolizumab and chemotherapy compared with placebo in combination with pembrolizumab and chemotherapy in participants with metastatic non-small cell lung cancer (NSCLC)

Non-small-cell lung cancer (NSCLC) is the most common form of lung cancer. Compared to small-cell lung cancer, NSCLC consists of larger cells when viewed under a microscope. It develops as a result of uncontrolled cell growth in the lungs and is usually triggered by smoking, environmental toxins, or genetic mutations. In advanced stages, a cure is rare, but modern therapies can prolong life. Standard treatment depends on the tumor mutations and, in many cases, consists of a combination of chemotherapy and immunotherapy, often using the drug pembrolizumab. This drug blocks a protein (PD-1) that tumors use to hide from the immune system. This makes the tumor cells visible to the immune system and triggers an immune response against them.

Eftilagimod alfa is a novel immunotherapy designed to further activate the immune system by more strongly stimulating immune cells via MHC class II molecules. MHC-II receptors on cell surfaces can present antigens and thus trigger an immune response.

The goal of this Phase 3 study is to determine whether the combination of the new active ingredient can improve overall survival and slow disease progression compared to standard therapy without eftilagimod. Patients will be randomly assigned to two study arms, and neither the patients nor the medical staff will know which drug combination is being administered; in other words, the study is blinded. Patients will receive either Eftilagimod alfa plus pembrolizumab and platinum-based chemotherapy (e.g., cisplatin or carboplatin with pemetrexed or paclitaxel) or a placebo along with the same standard medications. Treatment is administered over a period of up to two years.

Eligible participants include women and men aged 18 and older with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for the disease at this stage. There are no tumor DNA mutations in the EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) proteins, and the PD-L1 status is known. Pregnant and breastfeeding women are excluded from the study.