A phase 3 trial of consibelimab aims to enroll 560 patients with non–small cell lung cancer, who will be randomized to receive either consibelimab with chemotherapy, or chemotherapy alone.
A phase 3 trial of cosibelimab (CK-301) combined with chemotherapy in patients in first-line non-squamous non-small cell lung cancer (NSCLC) has been initiated, according to a press release by Checkpoint Therapeutics, Inc.
Cosibelimab is meant to block the interaction between PD-L1 and PD-1. The agent’s primary mechanism of action is based off the interaction of PD-L1 and PD-1 by removing the suppressive effects of PD-L1 on anti-tumor T-cells in order to restore cytotoxic T-cell response.
The parallel assignment, open-label CONTERNO study (NCT04786964), has a target enrollment of 560 participants and an estimated study completion date of May 2025. The primary end point of the trial is overall survival. Secondary end points include progression-free survival, objective response rate, duration of response, and the number of participants who experience an adverse event.
During the study, participants will be randomized 2:1 into either the experimental or control arm. In the experimental arm, patients will receive cosibelimab 1200 mg intravenously plus pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin area under the curve 5 on day 1 of every 3-week cycle for 4 cycles followed by cosibelimab 1200 mg plus pemetrexed 500 mg/m2 until progression.
During the control arm, patients will receive 500 mg/m2 intravenously plus cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1 of every 3-week cycle for 4 cycles followed by pemetrexed 500 mg/m2 until disease progression.
In order to participate in the study, patients must be 18 years of age or older, have a confirmed diagnosis of stage IV non-squamous NSCLC, have confirmation that epidermal growth factor receptor or anaplastic lymphoma kinase-directed therapy is not indicated, have measurable disease, have not received prior systemic treatment for advanced/metastatic NSCLC, can provide tumor tissue, have a life expectancy of at least 3 months, an ECOG performance status of 0 or 1, and have adequate organ function.
Patients with a predominantly squamous cell history NSCLC, has received prior systemic cytotoxic chemotherapy for metastatic disease, has received antineoplastic biological therapy, or has had major surgery less than 3 weeks prior to first dose, completed palliative radiotherapy within 7 days prior to the first dose of study medication, is expected to require any other form of antineoplastic therapy while on study, has clinically active diverticulitis, has known active central nervous system metastases, known hypersensitivity reaction to treatment with another monoclonal antibody, is receiving chronic systemic steroids, an active autoimmune disease, active infection requiring therapy, or has known uncontrolled or significant cardiovascular disease are not eligible to participate.
“We are excited to develop this combination in NSCLC, with the goal of extending the lives of patients with lung cancer and providing expanded access and fewer obstacles to potentially life-saving immunotherapy treatment, Our strategy since our founding has been to enter the largest markets in this class with a focus on highly competitive pricing, and there is no more impactful indication to execute on this approach than NSCLC with approximately 1.7 million new worldwide cases reported in 2020,” said James F. Oliviero, president and chief executive officer of Checkpoint, in a press release.