Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This phase II trial studies how well durvalumab works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as durvalumab, may be able to shrink tumors. Durvalumab may be effective in treating patients with squamous cell lung cancer.

Key Dates

Start date

Jul 31, 2014

Status verified

May 2023

Primary completion

Sep 30, 2018

Completion

Sep 30, 2020

Study Design

Enrollment

116 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (MEDI4736 - closed to accrual 12/2015)
  Patients receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (docetaxel - closed to accrual 4/2015)
  Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)
• Experimental: Arm III (MEDI4736 retreatment)
  For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Patients receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate in MEDI4736-treated Participants [ Time Frame: Up to 3 years post registration ]

Locations (993)

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