Phase 4
N=615
A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT03285763 ↗Enrolled (actual)
615
Serious AEs
32.2%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants With Adverse Events — 564 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atezolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
564 | — |
| SECONDARY Percentage of Participants Alive 2 Years After Initiation of Treatment |
26.7 | — |
| SECONDARY Overall Survival (OS) |
11.2 | — |
| SECONDARY Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1) |
2.7 | — |
| SECONDARY EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item |
328; 146; 97; 24; 1; 1 | — |
| SECONDARY EQ-5D-5L Questionnaire - Self-Care Item |
475; 66; 44; 8; 4; 1 | — |
| SECONDARY EQ-5D-5L Questionnaire - Usual Activities Item |
297; 164; 99; 16; 21; 257 | — |
| SECONDARY EQ-5D-5L Questionnaire - Pain/Discomfort Item |
206; 216; 129; 38; 7; 1 | — |
| SECONDARY EQ-5D-5L Questionnaire - Anxiety/Depression Item |
334; 163; 83; 13; 3; 1 | — |
| SECONDARY EQ-5D-5L Questionnaire - VAS Scores |
-0.51; -1.14; 0.97; 2.23; 1.78; 3.04 | — |
| SECONDARY European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13) |
24.82; 2.41; 1.59; -0.62; -0.50; -2.84 | — |
| SECONDARY Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST |
3.7 | — |
| SECONDARY Percentage of Participants Alive 3 Years After Initiation of Treatment |
19.6 | — |
| SECONDARY Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1 |
11.5 | — |
| SECONDARY Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST |
12.4 | — |
| SECONDARY Duration of Response as Assessed by the Investigator According to RECIST v.1.1 |
16.6 | — |
| SECONDARY Duration of Response as Assessed by the Investigator According to Modified RECIST |
20.5 | — |
Summary
This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.
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, after anti-PD-1 as monotherapy, or after TKI therapy). Participants with a previously detected sensitizing epidermal growth factor receptor (EGFR) mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion oncogene must have received targeted therapy (TKI) followed by at least one line of standard systemic chemotherapy prior to receiving atezolizumab. Overall, participants should not have received more than two lines of standard systemic chemotherapy. Participants who have discontinued first-line or second-line therapy due to intolerance are also eligible
- The last dose of prior systemic anticancer therapy or targeted therapy must have been administered more than or equal to (≥) 21 days prior to randomization.
- The last dose of prior anti-PD-1 therapy must have been administered. Nivolumab must have been discontinued >= 14 days and pembrolizumab >= 21 days prior to study treatment initiation, providing that these treatments were not administered in a clinical trial setting.
- Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
- Participants with asymptomatic central nervous system (CNS) metastases (treated or untreated), as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic evaluation, are eligible
- Eastern Cooperative Oncology Group (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 (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab
- Participants must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy
Exclusion Criteria
- 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 study treatment initiation
- 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 (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
- 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
- Inability to understand the local language(s) for which the EORTC QLQ-LC13 and EQ-5D-5L questionnaires are available
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoi
Data sourced from ClinicalTrials.gov (NCT03285763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.