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Genentech GO40241

Status:

Recruiting |Phase III

Official Title:

A Phase III, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy 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

Study Purpose:

To evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab in combination with platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in patients with resectable non-small cell lung cancer.

Interventions:

  • Study agents: Atezolizumab or placebo
  • Platinum–based chemotherapy (chemotherapy is per investigator choice)
  • Quality of Life questionnaires
  • ARM A: Atezolizumab plus Platinum-based chemotherapy for 4 cycles
  • ARM B: Placebo plus Platinum-based chemotherapy for 4 cycles
  • Surgery
  • Then unblinded and may receive Atezolizumab for 16 cycles

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Stage II, IIIA or IIIB (T3N2 only) Non-small cell lung cancer

Eligibility:

ECOG performance status 0 or 1.

Pathologically squamous or non-squamous histology.

Evaluation by the attending surgeon and medical oncologist to verify eligibility for RO resection.

Adequate pulmonary function.

Adequate cardiac function.

Adequate hematologic and end-organ function.

No active autoimmune diseases or deficiency.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Genentech GO40241

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!