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Phase 2 N=23 Treatment

A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung

Enrolled (actual)
23
Serious AEs
17.4%
Results posted
Apr 2023
Primary outcome: Primary: Objective Response Rate (ORR) — 18.2 Percentage of Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Atezolizumab (Drug); Bevacizumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hoffmann-La Roche
Primary completion
Jan 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (ORR)
18.2
SECONDARY
Duration of Objective Response (DOR)
6.36
SECONDARY
Time to Response (TTR)
1.577
SECONDARY
Disease Control Rate (DCR)
65.2
SECONDARY
Overall Survival (OS)
14.06
SECONDARY
Progression-Free Survival (PFS)
2.76
SECONDARY
PFS Rate at 6 and 12 Months
13.91; 4.64
SECONDARY
OS Rate at 1 and 2 Years
52.17; 30.43
SECONDARY
Percentage of Participants With Adverse Events
23
SECONDARY
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)
7; 1
SECONDARY
Objective Response Rate (ORR) According to iRECIST
17.4
SECONDARY
Disease Control Rate (DCR) According to iRECIST
65.2
SECONDARY
Duration of Objective Response (DOR) According to iRECIST
6.36
SECONDARY
Progression-Free Survival (PFS) According to iRECIST
2.76
SECONDARY
Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST
4.64
SECONDARY
Time to Deterioation (TTD) Using EORTC
NA; NA; NA; NA; NA; NA
SECONDARY
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status
53.409; 0.833; -0.521; -6.250; -15.625; -16.667
SECONDARY
Change From Baseline in Lung Cancer Related Symptoms
34.343; -5.556; -2.778; -4.630; -2.778; 5.556

Summary

This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.

Eligibility Criteria

Inclusion Criteria

  • Life expectancy ≥ 10 months
  • Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
  • No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:

Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.

  • TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment.
  • Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
  • ECOG Performance Status of 0-1
  • Adequate hematologic and end-organ function
  • Negative HIV test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
  • History of leptomeningeal disease
  • Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Current treatment with anti-viral therapy for HBV
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Tr
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04426825). 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.

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