About this trial

This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post-operative blood and tissue. A two-stage design will stop the study if fewer than 3 of the first 9 evaluable patients do not achieve MPR. An early stopping rule for safety will stop the study if more than 12 patients are enrolled to find the first 9 evaluable patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed NSCLC

Age > 18

ECOG Performance Status 0-1.

Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be > 0.8 L or be > 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.

Disqualifiers

Pathologically confirmed NSCLC *

Age > 18 *

ECOG Performance Status 0-1.

Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be > 0.8 L or be > 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.

Trial design

Design model

Single group

Treatments tested in this trial

Ipilimumab
Drug
1mg/kg IV on day 1 (1 dose total)
Nivolumab
Drug
3mg/kg (to a maximum of 240mg) IV on days 1, 15, 29 (+/- 3 days) (3 doses total)
SBRT
Radiation
1 fraction or 2 fractions delivered to the gross primary tumor and nodal disease, following the first treatment with ipilimumab + nivolumab on days 1-3.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Protocol TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Patients with a Pathologic Response

Assess Pathologic Response (major pathologic response and complete pathologic response) following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab.

Time frame

From beginning of study treatment to approximately day 49-63 on study.

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Assess safety and operative morbidity following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab and surgery.

Time frame

Beginning of study treatment through 90 days post study treatment completion.

BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab