Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer

Conditions

• Lung Atypical Carcinoid Tumor
• Lung Neuroendocrine Neoplasm
• Lung Non-Small Cell Squamous Carcinoma
• Minimally Invasive Lung Adenocarcinoma
• Neuroendocrine Carcinoma
• Recurrent Lung Adenocarcinoma
• Recurrent Lung Large Cell Carcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo stereotactic body radiation therapy

Study Details

This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.

Key Dates

Start date

Jun 26, 2017

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

140 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (stereotactic body radiation therapy)
  Patients undergo stereotactic body radiation therapy over 1-2 weeks.
• Experimental: Arm II (stereotactic body radiation therapy, nivolumab)
  Patients undergo stereotactic body radiation therapy over 1-2 weeks. Beginning within 36 hours before or after the first fraction of stereotactic body radiation therapy, patients also receive nivolumab IV over 30 minutes on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Event-free survival with events defined as local recurrence, regional recurrence, distant metastasis, secondary malignancy (including lung cancer), and death [ Time Frame: From the randomization date, assessed up to 5 years ]

Locations (3)

Find similar trials in Conroe, TX

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