Study design
NSCLC, lung adenocarcinoma, intolerable adverse reactions, Cancer
DISEASE PROGRESSION, ADVERSE EVENTS, LUNG ADENOCARCINOMA, MAY, NSCLC, CANCER
This study was a prospective, single‐center, single‐arm phase II clinical study that was approved by the Ethics Committee of Cancer Hospital, Chinese Academy of Medical Sciences (Approval Number:19/214‐1998). The registration number of Chinese Clinical Trial Registry is ChiCTR1900028112. The study was conducted in accordance with the Declaration of Helsinki. Informed consent was signed by all patients. The response rate to second‐line chemotherapy in historical control patients with non‐squamous NSCLC was 30%, which was expected to increase to 50% in this study. Simon's two‐stage design was performed with Patients with advanced lung adenocarcinoma who visited to Cancer Hospital, Chinese Academy of Medical Sciences, from May 2020 to October 2021 were enrolled in the study. Inclusion criteria: (1) Stage IV, All enrolled patients were treated with toripalimab (240 mg intravenously [IV] on Day 1, once every 3 weeks for 4 cycles). Anlotinib was taken orally once a day continuously on the first day through the 14th day of a 3‐week cycle. In the first stage, three patients were assigned to the dose‐escalation phase of anlotinib, and the administration method in cycle one was 8 mg daily for 14 consecutive days followed by 1‐week discontinuation. If the patient did not experience intolerable adverse reactions, the daily dose was increased to 12 mg at the beginning of the second cycle. For patients who are too weak to undergo dose adjustment, the 8‐mg dose was to be maintained from cycle two. If the first three enrolled patients could successfully transitioned to the 12‐mg treatment phase, the subsequent patients were directly given the 12‐mg dose for the first dose. This regimen was maintained until patients developed disease progression or had intolerable adverse events (AEs). If the criteria of stage I are met, the study shall enter stage II; if not, the study shall not enter stage II.