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NRG-LU007

Trial

Clinical Trial Title

RAndomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial

Trial Status

Open to Enrollment

Start Date

January 20, 2021

Location

Trial Type

Cancer - Adult Oncology

Specific Condition

Lung Cancer

Description

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

Eligibility Criteria

Eligibility Criteria

  • Pathologically proven diagnosis of extensive stage small cell lung cancer
  • Patients must be randomized within 9 weeks of last dose of etoposide/platinum or 6 weeks from completion of PCI
  • At the time of enrollment, patients must have had measurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
  • History/physical examination within 14 days prior to registration
  • Imaging within 42 days prior to registration to include:
  •   MRI brain with contrast or CT Brain with contrast
  •   CT chest, abdomen and pelvis or whole body PET/CT scan after the fourth cycle of chemotherapy
  • Age ≥ 18
  • ECOG Performance Status of 0-2 at the time of registration

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Friday, March 26, 2021 02:08:48 PM