Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer

Conditions

• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date

Nov 30, 2017

Status verified

Jun 2023

Primary completion

May 18, 2020

Completion

Mar 29, 2022

Study Design

Enrollment

67 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (tremelimumab, durvalumab)
  Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate [ Time Frame: From date of registration to progression or treatment discontinuation, up to 2 years and 5.5 months. ]

Locations (1021)

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