BEVACIZUMAB for Non-squamous non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Age ≥18 years"}
• {"criterion_text":"- Histologic documentation of primary non squamous non-small cell lung carcinoma"}
• {"criterion_text":"- Stage IV or IIIB disease with supraclavear metastatic nodes (according to TNM 7th edition)"}
• {"criterion_text":"- Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations, such as exon 21 L861Q, exon 18 G719S, G719A and G719C, exon 20 S768I and V769L). EGFR mutation testing must be performed at participating centres in a certified lab (AIOM-SIAPEC program or other European Quality Assurance [EQA] schemes)"}
• {"criterion_text":"- Clinical or radiologic evidence of disease (at least one target or non target lesion according to RECIST 1.1)"}
• {"criterion_text":"- ECOG performance status 0 to 2"}
• {"criterion_text":"- Life expectancy > 3 months"}
• {"criterion_text":"- Use of an acceptable mean of contraception for men and women of childbearing potential"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- EGFR T790M mutation alone or exon 20 insertions as unique mutation"}
• {"criterion_text":"- Tumors with a squamous component"}
• {"criterion_text":"- Prior chemotherapy or any other medical treatment for advanced NSCLC (previous neoadjuvant or adjuvant chemotherapy is allowed if > 6 months previously)"}
• {"criterion_text":"- Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if ≥ 14 days before randomization)"}
• {"criterion_text":"- Pregnancy or nursing"}
• {"criterion_text":"- Concomitant pathologies or laboratory alterations or concomitant medications use that prevent or contraindicate the use of erlotinib or bevacizumab"}

Primary endpoints

• {"endpoint_text":"- To test whether the combination of bevacizumab and erlotinib can prolong investigator assessed (IA-PFS) and blinded independent centrally-reviewed progression-free survival (BICR-PFS) as compared with erlotinib alone as first-line treatment in patients with NSCLC with activating mutation of EGFR. Note: CT (or other pertinent) scans performed at baseline and during follow-up will be collected and reviewed by an independent central panel of radiologists who will be blinded to the assigned tr","definition_or_measurement_approach":"Progression-free survival measured both by investigator assessment (IA-PFS) and by blinded independent central review (BICR-PFS); CT or other pertinent scans performed at baseline and during follow-up will be collected and reviewed by an independent central panel of radiologists blinded to treatment assignment."}

Secondary endpoints

• {"endpoint_text":"- To compare the two arms in terms of overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- To compare the two arms in terms of quality of life (EORTC C30 + LC13)","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 and LC13 instruments."}
• {"endpoint_text":"- To compare the two arms in terms of centrally reviewed objective response rate (RECIST v.1.1)","definition_or_measurement_approach":"Objective response rate assessed by central review using RECIST v1.1."}
• {"endpoint_text":"- To compare the two arms in terms of investigator assessed objective response rate (RECIST v.1.1)","definition_or_measurement_approach":"Objective response rate assessed by investigators using RECIST v1.1."}
• {"endpoint_text":"- To compare the two arms in terms of adverse events (CTCAE 4.03 version)","definition_or_measurement_approach":"Adverse events graded using CTCAE v4.03."}
• {"endpoint_text":"- To test whether an interaction exists between treatment arms and type of EGFR mutation (exon 19del vs exon 21 L858R vs other)","definition_or_measurement_approach":"Interaction analysis between treatment effect and EGFR mutation subtype as specified (exon 19del vs exon 21 L858R vs other)."}
• {"endpoint_text":"- To explore other possible predictive factors and their interaction with treatment arms","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

76

Number Of Sites

14

Number Of Participants

200

Primary sponsor

Full Name

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy