Comparing a new version of Bevacizumab with Avastin for lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a double-blind, randomized, multicenter study that evaluates the safety and efficacy of a new version of bevacizumab, developed by Mabscale, LLC, compared to the established drug Avastin® in combination with paclitaxel and carboplatin for treating advanced non-squamous non-small cell lung cancer (NSCLC). The study aims to demonstrate that the new bevacizumab is equivalent in effectiveness and safety to Avastin®. Participants will undergo pharmacokinetics assessments to further understand the drug's behavior in the body.

Why it matters

Who can join: the full rules

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

Where it's running

• Arkhangelsk Clinical Oncological Dispensary
  Arkhangelsk, Russia Recruiting
• State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
  Ivanovo, Russia Recruiting
• Kaluga Regional Clinical Oncology Dispensary
  Kaluga, Russia Recruiting
• Regional clinical oncological dispensary n.a.Sigal
  Kazan', Russia Recruiting
• Burdenko Main Military Clinical Hospital
  Moscow, Russia Recruiting
• Murmansk Regional Clinical Hospital
  Murmansk, Russia Recruiting

Study contacts

• Study coordinator: Alexander Generalov, MD
• Email: generalov.a@benerix.ru
• Phone: +74997149289

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Befotertinib with Bevacizumab or Chemotherapy for Lung Cancer Treatment

  This study is testing if a new lung cancer treatment combining befotertinib with either bevacizumab or chemotherapy can help patients with early-stage cancer that has an EGFR mutation feel better before surgery.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT06755684

• Combination therapy for advanced lung cancer with specific mutations

  This study tests a new combination treatment for advanced lung cancer patients with specific mutations to see if it helps them better than current options.

  Recruiting Phase 2 Dizal Pharmaceuticals · Shanghai, Shanghai Municipality · NCT06276283

• Furmonertinib treatment for advanced lung cancer with uncleared ctDNA

  This study is testing if a new lung cancer drug called furmonertinib works better alone or with other treatments for patients whose cancer has certain markers in their blood.

  Recruiting Phase 2 Sun Yat-sen University · Changchun and 25 other locations · NCT05334277

• Assessing the safety and effects of Azirkitug in cancer patients

  This study is testing a new cancer drug called Azirkitug to see how safe it is and how well it works for adults with certain types of lung and head and neck cancers.

  Recruiting at 47 sites Phase 1 AbbVie · Duarte, California and 47 other locations · NCT05005403

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.