About this trial

This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, 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. 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. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.

Eligibility criteria

Qualifiers

Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

NOTE: HIPAA authorization may be included in the informed consent or obtained separately

Age >= 18 years at the time of consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration

Disqualifiers

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

Has received prior temozolomide therapy

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial

Symptomatic central nervous system (CNS) metastases or untreated or actively progressing CNS metastases. Subjects with asymptomatic CNS metastases (treated or untreated) will be eligible provided all of the following criteria are met.

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Temozolomide

Treatment groups

56 Participants
are divided into 2 treatment groups

Locations

5
University of Illinois Cancer Center60612, ChicagoIllinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center46202, IndianapolisIndiana, United States
University of Iowa Hospitals and Clinics52242, Iowa CityIowa, United States
Ohio State University Comprehensive Cancer Center43210, ColumbusOhio, United States

Sponsors and collaborators

Dwight Owen

Lead sponsor

Big Ten Cancer Research Consortium

Sponsor institution

Genentech, Inc.

Collaborator