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

Recruiting in Palo Alto (17 mi)

Overseen byTina Cascone

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patients with stage I-IIIA disease and IIIB (T3N2 only, and N2 single station), according to American Joint Committee on Cancer (AJCC) 8th edition, are eligible for arm A of the study. Patients with stage III, N2 single station, must not have more than one mediastinal lymph node station involved by tumor All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease

The patient must be a suitable candidate for surgery, in the opinion of the treating physician

Predicted forced expiratory volume in 1 second (FEV1) >= 50%

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Treatment Details

Interventions

Bintrafusp Alfa (Checkpoint Inhibitor)
Therapeutic Conventional Surgery (Procedure)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (bintrafusp alfa, surgical resection)Experimental Treatment2 Interventions

Patients receive bintrafusp alfa 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.

Bintrafusp Alfa is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Bintrafusp Alfa for: