Trials
Search / Trial NCT05654454

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

Trial Information

Current as of January 17, 2025

Recruiting

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

About Mabscale, Llc

Mabscale, LLC is a pioneering biopharmaceutical company dedicated to advancing innovative therapies in the field of antibody-based treatments. With a focus on developing scalable and efficient manufacturing processes, Mabscale aims to enhance the accessibility and affordability of monoclonal antibodies for various therapeutic applications. The company is committed to rigorous research and development, ensuring high-quality clinical trials that adhere to regulatory standards. By leveraging cutting-edge technology and a team of experienced professionals, Mabscale strives to make significant contributions to the treatment landscape, ultimately improving patient outcomes and quality of life.

Locations

Moscow, , Russian Federation

Smolensk, , Russian Federation

Ufa, , Russian Federation

Volgograd, , Russian Federation

Arkhangel'sk, , Russian Federation

Ivanovo, , Russian Federation

Kaluga, , Russian Federation

Saint Petersburg, , Russian Federation

Saint Petersburg, , Russian Federation

Kazan', , Russian Federation

Moscow, , Russian Federation

Moscow, , Russian Federation

Novosibirsk, , Russian Federation

Omsk, , Russian Federation

Samara, , Russian Federation

Smolensk, , Russian Federation

Perm, , Russian Federation

Murmansk, , Russian Federation

Saint Petersburg, , Russian Federation

Saint Petersburg, , Russian Federation

Saint Petersburg, , Russian Federation

Saint Petersburg, , Russian Federation

Kaluga, , Russian Federation

Nizhny Novgorod, , Russian Federation

Pushkin, , Russian Federation

Kaluga, , Russian Federation

Tver, , Russian Federation

Yaroslavl, , Russian Federation

Veliki Nóvgorod, , Russian Federation

Perm, , Russian Federation

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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