Multicenter randomized phase II trial of neoadjuvant radioimmunotherapy versus chemoimmunotherapy in patients with clinical stages IB-III (N2) non-small cell lung cancer

Clinical Trial Details

In this clinical trial, we hope to learn the effectiveness of cemiplimab with chemotherapy or cemiplimab with stereotactic body radiation therapy (SBRT) as treatment for clinical stage IB-III (N2) non-small cell lung cancer prior to surgery and cemiplimab for one year following surgery.

Cemiplimab is approved by the U.S. Food and Drug Administration (FDA) for advanced disease, however, it is considered investigational in this study because it is not approved for early-stage disease.

Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

One group will receive cemiplimab with chemotherapy and the other group will receive cemiplimab with stereotactic body radiation therapy (SBRT) prior to surgery. Cemiplimab is administered intravenously through an IV.

Participation includes a 28-day screening period, a 7-week preoperative treatment period (every 3 weeks), and surgical resection, followed by 12 months of post-surgical treatment (every 3-6 weeks), and a 5-year follow-up period from surgery (every 6 months for 2 years then yearly for 3 years).

Total study participation will last approximately 5 years.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed by a biopsy with clinical stage IB, II, IIIA (N2) non-small cell lung cancer.
Participants who are considered eligible for surgical resection by their thoracic surgeon.
No known EGFR mutations or ALK fusions.
No prior therapy for lung cancer.
Participants must not have known HIV, active hepatitis B or C or who are pregnant or breastfeeding.

Detailed eligibility will be reviewed when you contact the study team.

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