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Clinical Trial 18871

Cancer Type: Thoracic
Interventions:Atezolizumab (Tecentriq)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Eric Haura

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase II, Open-Label, Multicenter, Single-Arm Study To Investigate TheEfficacy And Safety Of Atezolizumab As Neoadjuvant And Adjuvant Therapy In Patients With Stage Ib, Ii, Iiia Or Selected Iiib Resectable And Untreated Non-Small Cell Lung Cancer

Summary

The purpose of this study is to find out what effects, good or bad, atezolizumab has on participants and their lung cancer when given before and then after surgery. Atezolizumab is an antibody (a large protein that is used by the immune system to fight foreign substances such as bacteria, viruses, and tumor cells) that affects the immune system by blocking the PD-L1 pathway. The PD L1 pathway is involved in decreasing the body's natural immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumors.

Objective

*To evaluate the efficacy of atezolizumab as neoadjuvant treatment for Stage IB, II, and IIIA NSCLC. *To evaluate the efficacy of atezolizumab as neoadjuvant treatment for Stage IB, II, and IIIA NSCLC. *To evaluate response to atezolizumab in patients with PD-L1-positive vs. PD-L1-negative tumors. *To evaluate if mutations in genes commonly involved in NSCLC, as well immune-function genes, are related to response to atezolizumab treatment. *To evaluate the efficacy of atezolizumab treatment. *To evaluate the safety and tolerability of atezolizumab. *To evaluate the immune response to atezolizumab. *To investigate changes in tumor cell infiltrate in lymph nodes following atezolizumab treatment. *To determine the ability to induce tumor-specific immune responses with autologous T cells and identify the mutant epitopes on major histocompatibility complex class I (MHC I) that elicit this response. *To investigate the ability of atezolizumab to restore functional status of exhaustive TAA-specific CD4 and CD8 T cells at the tumor site and in peripheral blood. *To determine if serum micro RNA (miRNA), microvesicle-associated proteins, soluble PD-L1, MICA, or MICB change with atezolizumab treatment or are predictive of response. *To determine if expression of or mutation in any other gene or protein may be a predictive biomarker of pathologic response. *To evaluate other evidence of treatment effect, including apoptosis, PD-1 and PD-L1 expression by tumor and immune cells, and immune modulatory effects in tumor-infiltrating immune cells and lymph nodes.

Inclusion Criteria

  • Pathologically documented Stage IB, II, or IIIA Non-Small Cell Lung Cancer (NSCLC) and eligible for surgical resection with curative intent
  • Adequate pulmonary and cardiac function
  • Available biopsy of primary tumor with adequate samples
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end-organ function
  • Agreement to remain abstinent or use appropriate contraception, among women of childbearing potential

  • Exclusion Criteria

  • NSCLC that is clinically tumor size T4 by virtue of mediastinal organ invasion or Stage IIIB by vitrue of N3 disease.
  • Any prior therapy for lung cancer including chemotherapy, hormone therapy or radiotherapy within 3 years.
  • Patients with prior lung cancer that have been in remission for less than 3 years.
  • Prior treatment with anti-PD-1 or PD-L1 therapies
  • Major surgery within 28 days prior to Day 1 of Cycle 1
  • History or risk of autoimmune disease
  • Hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Active hepatitis B (chronic or acute)
  • Active hepatitis C virus (HCV) infection
  • Active tuberculosis
  • Administration of live attenuated vaccines within 4 weeks before Cycle 1, Day 1 or at any time during study.
  • Severe infections within 4 weeks prior to Cycle 1 Day 1 including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1
  • Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1 Day 1 (or within five half-lives of the investigational product, whichever is longer)
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Pregnant or lactating, or intending to become pregnant during the study
  • Additional criteria apply