A Randomized Phase II Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients with Resectable Non-Small Cell Lung Cancer
Details
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned.
The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
The study is also looking at several other research questions, including:
What are the side effects associated with the investigational treatments in comparison to the control treatment?
Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed?
How much of the study drug(s) are in the blood at a given time?
Does the body make antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)?
Eligibility
You can join if...
General Key Inclusion Criteria:
Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
Adequate organ and bone marrow function, as described in the protocol
General Key Exclusion Criteria:
Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
Presence of >/= grade 2 peripheral neuropathy
Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Arm 1:
Grade >/= 3 hypercalcemia, as defined in the protocol
Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply.