Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER)

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small cell lung carcinoma (NSCLC) harbouring activating EGFR (exon 19 deletion or L858R) and T790M resistance mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Thoracic Oncology Platform
• Collaborators: AstraZeneca; Hoffmann-La Roche
• Treatments: Bevacizumab; Osimertinib

Criteria

Inclusion Criteria:

• Patients (male/female) must be >18 years of age.

• Patients diagnosed with NSCLC, stage IIIb/IIIc (not amenable to radical therapy) or IVa/IVb according to 8th TNM classification, after progression following prior EGFR TKI therapy (erlotinib, gefitinib, dacomitinib or afatinib) as the most recent treatment regimen;

• Pathological diagnosis of predominantly non-squamous NSCLC;

• Maximum one line of previous platinum based chemotherapy;

• Histological or cytological confirmation of EGFRm (exon 19 deletion or exon 21L858R);

• Locally confirmed T790M mutation determined from biopsy (preferred) or on circulating tumour DNA, documented in tissue, plasma or serum after disease progression on the most recent treatment regimen;

• Plasma, serum, and tumour (preferred) tissue or cytology (if biopsy was taken and FFPE tumor material is not yet fully depleted) after disease progression on the most recent EGFR TKI treatment available for central confirmation of T790M;

• Measurable or evaluable disease according to RECIST 1.1;

• Adequate haematological, renal and liver function;

• World Health Organization (WHO) performance status 0-2.

Exclusion Criteria:

• Patients with mixed NSCLC with predominantly squamous cell cancer, or with any small cell lung cancer (SCLC) component;

• Symptomatic or active central nervous system metastases, as indicated by progressive growth or increasing need of steroids.

• Patients currently receiving medications or herbal supplements known to be potent CYP3A4 inducers;

• Patients with any unresolved toxicities from prior therapy greater than CTCAE V 4.0 grade 1 (exception: alopecia & grade 2, prior platinuma-therapy related neuropathy)

• Previous treatment with osimertinib and/or bevacizumab;