NCT04560686

Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer

Phase II Study of Neoadjuvant Immune Checkpoint Blockade-Based Therapy With M7824 (Bintrafusp Alpha) for Untreated Resectable Non-Small Cell Lung Cancers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Resectable Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Bintrafusp Alfa	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2020-08-05
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-09-23
• Last updated: 2022-07-28
• Results posted: 2022-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study