Clinical trial NCT03922997: A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: An Open-Label, Singe Arm, Multicenter Study to Investigate the Safety and Efficacy of Atezolizumab (Tecentriq) in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene will be excluded from this study. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible.
* The last dose of prior systemic anticancer therapy must have been administered ≥ 21 days prior to the first study treatment.
* The last dose of prior anti-PD-1 therapy must have been administered
* Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
* Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
* ECOG performance status 0, 1, or 2
* Life expectancy ≥ 12 weeks
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
* Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy

Exclusion Criteria:

* Patients with EGFR mutation or ALK fusion oncogene
* Symptomatic CNS metastases
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to the first study treatment
* Leptomeningeal disease
* Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
* Pregnant or lactating, or intending to become pregnant during the study
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
* Significant cardiovascular disease
* Significant renal disorder requiring dialysis or indication for renal transplant
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
* Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
* Prior allogeneic stem cell or solid organ transplantation

Primary outcomes:
measure: Serious Adverse Event Incidence Rates
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
measure: Overall Survival (OS) Rate
timeFrame: Baseline to 2 years
measure: OS
timeFrame: Baseline up to approximately 3 years
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to approximately 3 years
measure: Objective Response Rate (ORR)
timeFrame: Baseline up to approximately 3 years
measure: Duration of Response (DOR)
timeFrame: Baseline up to approximately 3 years
measure: EQ-5D-5L Index-Based and VAS scores
timeFrame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years)
measure: EORTC QLQ-LC13 score
timeFrame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years)
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
city: Harbin
country: China
facility: Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center; Medical Oncology
city: Urumqi City
country: China
facility: Cancer Hospital Affliated to Xinjiang Medical University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: