A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02409355
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
• Scientific title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
• Date of first enrolment: May 7, 2015
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02409355
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Brazil, Czech Republic, Czechia, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically or cytologically confirmed Stage IV squamous NSCLC

- Tumor programmed death-ligand 1 (PD-L1) expression, as determined by
immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at
screening

- No prior treatment for Stage IV squamous NSCLC

- Measurable disease as defined by RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic and end-organ function

Exclusion Criteria:

- Active or untreated central nervous system (CNS) metastases

- Untreated or inadequately treated spinal cord compression

- Leptomeningeal disease

- Uncontrolled pleural effusion, pericardial effusion, or ascites

- Uncontrolled tumor-related pain

- Uncontrolled hypercalcemia

- Any other malignancies within 5 years except those with negligible risk of metastasis
or death

- Pregnant or lactating women

- Known hypersensitivity to any component of atezolizumab formulation or other study
medication

- History of autoimmune disease except controlled, treated hypothyroidism or type I
diabetes

- Prior allogeneic bone marrow or solid organ transplantation

- Positive human immunodeficiency virus (HIV) test

- Active hepatitis B or C

- Active tuberculosis

- Significant cardiovascular disease

- Severe infection or major surgery within 4 weeks prior to randomization

- Use of any approved anti-cancer therapy within 3 weeks prior to treatment

- Use of an investigational agent or participation in another clinical trial within 4
weeks prior to randomization

- Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4
weeks prior to randomization

- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint
blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic
antibodies

- Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents
within 2 weeks prior to randomization



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Cisplatin

Drug: Carboplatin

Drug: Gemcitabine

Drug: Atezolizumab

Primary Outcome(s)

Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)]

Secondary ID(s)

GO29432

2014-003106-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02409355