Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy

Conditions

• Lung Non-Squamous Non-Small Cell Carcinoma
• Radiation-Induced Pneumonitis
• Stage II Lung Non-Small Cell Cancer AJCC v7
• Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
• Stage III Lung Non-Small Cell Cancer AJCC v7
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7
• Stage IIIB Lung Non-Small Cell Cancer AJCC v7
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Nintedanib — DRUG
  Given PO
• Placebo — OTHER
  Given PO
• Quality-of-Life Assessment — PROCEDURE
  Ancillary studies

Study Details

This trial studies the side effects and how well nintedanib works compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and may prevent the growth of new blood vessels. It may also help reduce the recurrence of non-small cell lung cancer.

Key Dates

Start date

Jun 29, 2015

Status verified

Mar 2020

Primary completion

Jun 10, 2019

Completion

Jun 10, 2019

Study Design

Enrollment

8 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (nintedanib)
  Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
• Placebo Comparator: Arm II (placebo)
  Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III (nintedanib, durvalumab)
  Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Portion of Common Terminology Criteria for Adverse Events Grade 2 or Higher Radiation Pneumonitis [ Time Frame: At 6 months after completion of chemoradiation ]

Locations (1)

Find similar trials in Buffalo, NY

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