An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Male and female patients over the age of 18 with ECOG status of 0-1
• Patients with histologically confirmed Stage IV or recurrent NSCLC squamous
or non-squamous histology, with no prior systemic anticancer therapy (including
EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic
disease.
* - Prior adjuvant or neoadjuvant chemotherapy is permitted as long as the last
administration of the prior regimen occurred at least 6 months prior to
enrollment.
* - Prior definitive chemoradiation for locally advanced disease is also
permitted as long as the last administration of chemotherapy or radiotherapy
(which ever was given last) occurred at least 6 months prior to enrollment.
• Measurable disease by CT or MRI per RECIST 1.1.
• Patients must have tissue submitted during screening (fresh biopsy or achival
sample not older than 3 months) for biomarker testing. Treatment may start
before test results are received.
• Women of childbearing potential must not be breastfeeding and must have a
negative serum or urine pregnancy test within 24 hours prior to start of study
treatment. This test will be repeated every 4 weeks during the study. Patients
must follow the contraception requirements while enrolled in the study.

Exclusion Criteria

• Patients previously treated with drugs targeting T-cell co-stimulation or
checkpoint pathways
• Patients with known EGFR mutations or ALK translocations sensitive to
available targeted inhibitor therapy
• Patients with untreated central nervous system metastases
• Patients with an active, known or suspected autoimmune disease. Patients with
type I diabetes mellitus, hypothyroidism only requiring hormone replacement,
skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring
systemic treatment, or conditions not expected to recur in the absence of an
external trigger are permitted to enroll.
• Patients with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalent) or other
immunosuppressive medications within 14 days of enrollment.
• Patients with interstitial lung disease or who are incarcerated or
temporarily detained for psychiatris of physical illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br>- The clinical efficacy will be measured by the analysis endpoint of objective<br /><br>response rate (ORR). The association of ORR with baseline tissue TMB and blood<br /><br>TMB will be assessed using logistic regression model.<br /><br>- The correlation between baseline tissue TMB and bloodTMB will be assessed<br /><br>using Spearman correlation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>- Objective response rate (ORR), Progression free survival (PFS), Overall<br /><br>survival (OS)<br /><br>- Incidence of adverse events, serious adverse events, and select adverse<br /><br>events</p><br>