A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer

Launched by MABSCALE, LLC · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced non-small cell lung cancer (NSCLC) using a medication called bevacizumab, made by Mabscale, LLC, compared to a well-known drug called Avastin®. Both treatments are combined with two chemotherapy drugs, paclitaxel and carboplatin. The goal is to find out if the new medication is just as safe and effective as Avastin® for patients whose cancer is difficult to treat or has spread to other parts of the body.

To participate in this trial, patients need to be at least 18 years old and have been newly diagnosed with stage IIIB/C or IV non-small cell lung cancer, or have cancer that has come back after treatment. They should also have a confirmed diagnosis and be able to receive the study treatment safely. Participants will be monitored closely and can expect regular check-ups to evaluate their health and how well the treatment is working. It's important to note that certain conditions, like specific genetic mutations or recent surgeries, may exclude someone from joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Male and female patients at least 18 years of age
• • Newly diagnosed Stage IIIB/C or IV non-small cell lung cancer (according to Revised Cancer Staging by American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) 8th edition) or recurrent non-small cell lung cancer (NSCLC)
• • Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• • Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC
• • Presence of at least 1 measurable tumour as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• • Neutrophils ≥ 1,5 × 10\^9/L
• • Platelets ≥ 100 × 10\^9/L
• • Haemoglobin ≥ 90 g/L
• • Bilirubin level ≤ 1.5 × upper limit of normal (ULN)
• • Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) levels \< 3 × ULN (\< 5 × ULN for patients with liver metastases)
• • Alkaline phosphatase level \< 3 × ULN (\< 5 × ULN for patients with liver or bone metastases)
• Exclusion Criteria:
• • Known sensitizing EGFR mutations or ALK translocation positive mutations
• • Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed
• • Major surgery 28 days before inclusion into the study
• • Minor surgery 7 days before inclusion into the study
• • Stage II or higher of neuropathy or ototoxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, excluding trauma
• • Life expectancy less than 6 months
• • Metastases to central nervous system or carcinomatous meningitis
• • Pregnancy or lactation