Testing the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy Treatment During Radiation Therapy for Superior Sulcus Non-small Cell Lung Cancer

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IIB Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Superior Sulcus Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — BIOLOGICAL
  Given IV
• Biopsy — PROCEDURE
  Undergo tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo PET/CT scan
• Etoposide — DRUG
  Given IV
• External Beam Radiation Therapy — RADIATION
  Undergo external beam radiation therapy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Paclitaxel — DRUG
  Given IV
• Pemetrexed — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT scan
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery

Study Details

This phase II trial tests the effect of atezolizumab given with usual chemotherapy during radiation therapy in treating patients with superior sulcus non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, etoposide, paclitaxel and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving atezolizumab with usual chemotherapy and radiation therapy may lower the chance of the tumor from growing or spreading.

Key Dates

Start date

Sep 9, 2021

Status verified

Sep 2023

Primary completion

May 10, 2031

Completion

May 10, 2031

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (atezolizumab, chemotherapy, RT, surgery)
  Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Within 42 days after completion of surgery, patients then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
• Active Comparator: Arm II (chemotherapy, RT, surgery)
  Patients receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients also undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.

Primary Outcome Measure

Pathologic complete response (pCR) by local review [ Time Frame: Up to 6 years ]

Locations (46)

Find similar trials in Jonesboro, AR

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