Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease

Lung Cancer Clinical Trial

Official title:

Nivolumab and Ablation For Patients With Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease: A Brown University Oncology Research Group Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02469701
• Other study ID #: BrUOG 317
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nivolumab releases the inhibition of the immune system against human cancers. Dramatic and sustained activity has been observed in advanced lung cancer. Ablation may stimulate the immune system by exposing new tumor antigens. Since tumors that express PD-L1 may be more likely to respond to nivolumab, if ablation increases PD-L1 expression (which has not been studied) this treatment may enhance the activity of nivolumab at both the treated site and in other, non-treated, tumors. Ablation is already an FDA approved treatment for cancer. Nivolumab was recently FDA approved for second line treatment of advanced squamous cell NSCLC. The goal of the study will be to determine if the combination of nivolumab and ablation has higher systemic activity than previously reported with nivolumab alone.

Description:

See summary above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically or cytologically confirmed NSCLC

• Stage IIIB or stage IV.

• Patient to meet either criterion A or B:

A) Progression after at least 1 line of systemic treatment (IV or oral) for metastatic or locally advanced disease. Must provide documentation systemic treatment was for either locally advanced or metastatic and also scan or assessment to show progression. Radiation does not count as 1 line.

B) Patients progressing within 6 months of completion of neoadjuvant or adjuvant chemotherapy are also eligible without having treatment for metastatic disease (for example patient with stage I disease undergoes resection, receives systemic chemotherapy and then progresses to the liver (now stage IV) within 6 months of chemotherapy). Radiation does not count as 1 line.

• Ablation for advanced lung cancer is being considered by the treating physician for treatment or prevention of symptoms such as pain, bleeding or obstruction- Documentation is required in writing by MD for this criterion.

• At least 1 site of measurable disease that will not be treated with ablation. Sites to send confirmation on which lesion of measurable disease will not be ablated for tracking of response.

• At least 3 weeks since prior chemotherapy and radiation therapy

• No brain metastases except for patients whose metastases have been removed by surgical resection or have had stereotactic radiation or gamma knife with no evidence of active disease on MRI within 28 days of starting treatment.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

• Life expectancy of at least 12 weeks.

• Required entry laboratory parameters within 14 days of study entry: Granulocytes = 1000/µl; platelet count =75,000/µl; absolute lymphocyte count = 500/ µl; Creatinine = 1.5x upper limit normal mg/dl; Bilirubin < 1.5x upper limit normal; AST = 3 x upper limit of normal.

• Age > 18 years

• Men and women of childbearing potential enrolled in this study must agree to use adequate barrier birth control measures during the course of the study and up to 2 months after.

• Written informed consent.

Exclusion Criteria:

• Patients with a history of clinically significant chronic autoimmune disease

• Prior therapy with antibodies that modulate T-cell function defined as anti-CTLA-4, anti-PD-1, and anti-PD-L1

• Conditions currently requiring immunosuppressive medications

• Known history of HIV or hepatitis B or C

• Bleeding diathesis or coagulopathy that in the investigators opinion would prevent ablation from being safely performed.

• Patients with unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.

• History of organ allograft even if not taking immunosuppressive medications

• Pregnant or breast-feeding.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Lung Cancer
• Neoplasm Metastasis
• Non-small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• nivolumab and ablation

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
howard safran	Rhode Island Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate of the Combination of Ablation and the PD-1 Inhibitor Nivolumab for Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Progressed Following at Least 1 Prior Chemotherapy Regimen for Metastatic or Locally Advanced Disease.	Assessment of tumor response by scan 12 weeks post the first dose of Nivolumab and approximately every 12 weeks after. Post progression by RECIST a 1 month confirmatory scan will be done and that will be the indicator of Progression.	Up to 5 years.