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Brief Title: SBRT/LDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1/L1 Inhibitor and Chemotherapy
Official Title: SBRT/LDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1/L1 Inhibitor and Chemotherapy:a Prospective Exploratory Study
Study ID: NCT04878107
Brief Summary: SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumab,apatinib and SBRT/LDRT in patients with metastatic non-small Cell Lung Cancer (NSCLC) patient previously treated With PD-1/L1 Inhibitor and Chemotherapy.
Detailed Description: SABRE STUDY consists of two stages. first stage of this trial is a single-arm study that requires enrolling at least 18 patients, all of whom would receive the treatment of SBRT/LDRT in combination with apatinib plus camrelizumab.The trial would proceed into the second stage if 4 or more patients achieve CR/PR. Otherwise, the trial is stopped early due to futility as we fail to reject the null. In the second stage, at least 70 patients are equally randomized into two arms to receive "SBRT/LDRT in combination with apatinib plus camrelizumab" or "SBRT + docetaxel" . Stratified-area group randomization would be used.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Name: CongHua Xie, MD
Affiliation: Wuhan University
Role: PRINCIPAL_INVESTIGATOR
Name: You Lu, MD
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR