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Clinical Trial Summary

This phase II trial studies how well bintrafusp alfa before surgery works in treating patients with non-small cell lung cancer for which the patient has not received treatment in the past (untreated) and that can be removed by surgery (resectable). Immunotherapy with bintrafusp alfa may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bintrafusp alfa before surgery may help lower the risk of the cancer coming back after surgery.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the rate of major pathologic response (MPR). OUTLINE: Patients receive bintrafusp alfa intravenously (IV) on days 1, 15, and 29 in the absence of unacceptable toxicity. Within 4-6 weeks after last dose of bintrafusp alfa, patients undergo surgery at the discretion of the treating surgeon. Within 8 weeks after surgery, patients may receive chemotherapy or undergo radiation therapy at the discretion of the treating physician. After completion of study treatment, patients are followed for up to 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04560686
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date August 5, 2020
Completion date July 1, 2021

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