Brief Summary
This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, individually called a “study drug” or collectively called “study drugs”. ‘Investigational’ means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advancedat a late stage, far along non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (NSCLC).
The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much of each study drug is in your bloodthe red bodily fluid that transports oxygen and other nutrients around the body at different times
- Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
- How administering the study drugs might improve your quality of lifethe overall well-being of a person diagnosed with cancer, encompassing both physical and emotional aspects of health
Intervention / Treatment
- Drug: fianlimab
- Drug: cemiplimab
- Drug: Pemetrexed
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Placebo
Key Inclusion Criteria:
- Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resectionsurgical removal of tissue or part/all of an organ or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC.
- Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissuea group of cells that work together to perform a function sample, without intervening therapy between biopsyremoval of a section of tissue to analyse for cancer cells collection and screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening as described in the protocol
- For enrollment in phase 2, patients should have PD-L1, expression results (regardless of expression level) determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have a valid PD-L1 result, regardless of expression level, using an assay as performed by a central laboratory, as described in the protocol.
- At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imagingtests that create detailed images of areas inside the body (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of ≤1.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function as defined in the protocol.