Non-Small Cell Lung Cancer
Conditions
Brief summary
This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
Interventions
DRUGAtezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
DRUGCarboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
DRUGCisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m\^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
DRUGGemcitabine
Gemcitabine will be administered at 1000 mg/m\^2 (when coadministered with carboplatin) or 1250 mg/m\^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years) |
Countries
Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, Serbia, South Korea, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atezolizumab Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit. | 4 |
| Gemcitabine + Cisplatin/Carboplatin Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Study terminated by Sponsor | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Atezolizumab | Gemcitabine + Cisplatin/Carboplatin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 1 / 4 |
| other Total, other adverse events | 4 / 4 | 3 / 4 |
| serious Total, serious adverse events | 1 / 4 | 1 / 4 |
Outcome results
Primary
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)
Population: The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study. The planned outcome measures of this study are no longer applicable. The outcome measures were removed in the last protocol version.