Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)

Sponsor
Formycon AG
Study ID
NCT06643117
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FYB206 — BIOLOGICAL
    FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)
  • FYB206 — BIOLOGICAL
    Open-label treatment with FYB206 combined with chemotherapy (Cycles 18-34) to assure treatment continuation for trial patients up to a total of 2 years (a total of 34 treatment cycles)
  • Keytruda — BIOLOGICAL
    Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)

Study Details

NSCLC is the most common type of lung cancer. Metastatic cancers are cancers that start to spread to other parts of the body. NSCLC is treated by radiation therapy, with medicines, surgery, or immunotherapy. Immunotherapy is a type of treatment that helps the immune system fight cancer. The immune system helps the body fight infections and disease. Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Some cancer cells develop a way to hide from the body's immune system and, thus, allow the cancer cells to spread and grow. Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide. Pembrolizumab is a biologic drug (produced by living organisms) available in the market under the brand name Keytruda. Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery. This helps prevent the cancer from returning, improving overall survival. FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical, but very similar to its original biologic. Biosimilars are expected to have a similar effect and safety to the original biologic. This clinical trial is intended to demonstrate the comparable effectiveness and safety of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC who have not received previous anti-cancer treatment that is given directly into the blood.

Key Dates

Start date
Oct 3, 2024
Status verified
Jun 2025
Primary completion
May 13, 2025
Completion
May 13, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FYB206
  • Active Comparator: Keytruda

Primary Outcome Measure

Best objective response rate [ Time Frame: 40 Weeks ]

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