drugset / Trial / NCT02001168

Comparison of Postoperative Adjuvant Chemotherapy With/Without Rh-endostatin on Non-small Cell Lung Cancer in PhaseⅠB

NCT02001168

Phase 3 Unknown 392 enrolled Xinjiang Medical University
RandomizedParallel-groupOpen-labelPrevention

Summary

* Lung cancer is one of causes of the malignant tumor-associated death on a global scale, in which the surgery is the only effective approach in patients with non-small cell lung cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC is 40%, while only 4%~15% patients can benefit from adjuvant chemotherapy\[1\]. American National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant chemotherapy can be performed on NSCLC patients in phase Ⅱ~ⅢA. * In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB or which kind of patients would benefit from it after the establishment of new staging, a multi-subject group of lung cancer set up a perspective, randomized, open clinical trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase ⅠB under new staging policy, and to collect the characteristics of patients who could benefit from the treatment and the better adjuvant drugs after operation.

Timeline

Start
2013-10
Primary completion
2020-12
Completion
2022-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2
Subject Docetaxel Small molecule 60 mg/m2
Subject Endostar Protein / enzyme biologic 7.5 mg/m2
Subject Pemetrexed Small molecule 500 mg/m2