Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)

Conditions

• Lung Cancer, Nonsmall Cell, Stage I

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  560 mg given by mouth daily in a 28 day cycle.
• Nivolumab — DRUG
  3 mg/kg by vein beginning with Cycle 2 on Days 1 and 15 of every 28 day cycle.

Study Details

The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then in combination with Opdivo (nivolumab) can control NSCLC in patients who have received previous chemotherapy treatment.

Key Dates

Start date

Dec 31, 2016

Status verified

Feb 2017

Primary completion

Dec 31, 2019

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ibrutinib + Nivolumab
  Ibrutinib administered by mouth daily in 28 day cycles. Nivolumab administered by vein beginning with cycle 2, and given on Days 1 and 15 of every 28 day cycle.

Primary Outcome Measure

Response Rate in Participants with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Treated with Ibrutinib Followed by a Combination of Ibrutinib and Nivolumab [ Time Frame: 8 weeks from start of combination therapy ]