China-based biopharmaceutical company Innovent Biologics has dosed the first patient in the Phase III ORIENT-11 trial designed to evaluate sintilimab (IBI308) as first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC).
The randomised, double-blinded, multicentre trial intends to study sintilimab or placebo along with pemetrexed and platinum-based chemotherapy as first-line treatment to advanced or ns-NSCLC patients in China.
The trial is currently treating patients with the study drug combination in four cycles, followed by a maintenance treatment of sintilimab or placebo in combination with pemetrexed until the first occurrence of disease progression, intolerable toxicity, withdrawal of consent, death, or other specified events of the trial.
Approximately 378 patients with advanced or recurrent ns-NSCLC, who have not received previous systemic anti-tumour therapy, are expected to be enrolled in the trial.
The patients will be randomised and included in experimental and control group in a 2:1 ratio to receive the study drugs.
Out of the total patients, 252 will be included in the sintilimab group (experimental group) and 126 in the placebo group (control group).
The trial’s primary endpoint is progression-free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and as assessed by an Independent Radiological Review Committee (IRRC).
Innovent founder, CEO and chairman Michael Yu said: “Lung cancer has the highest morbidity and mortality among malignant tumours in China.
“With sintilimab entering phase III clinical trial for lung cancer, we hope to provide more treatment options for lung cancer patients in the future.”
Sintilimab, a fully human anti-PD-1 antibody, has been developed by Innovent in partnership with Eli Lilly and Company in China.