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)

NCT06643117 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: FYB206-C3-022023-509766-37-00
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 13

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; Non-Squamous Non-Small Cell Lung Cancer

Keywords

pembrolizumab; biosimilar; lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Best objective response rate

  Best objective response rate (bORR): proportion of patients who had a best response of complete response (CR) or partial response (PR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

  40 Weeks

Study Arms (2)

FYB206

EXPERIMENTAL

Biological: FYB206

Keytruda

ACTIVE COMPARATOR

Biological: Keytruda

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

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)

Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
• Confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated (ie, documentation of absence of tumor-activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements).
• No prior systemic treatment for metastatic non-squamous NSCLC. Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
• Known one of the mutations listed below:
• ROS1 fusion gene
• BRAF-V600E
• RET fusion
• MET Exon 14
• Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and are also off steroids 3 days prior to dosing with trial treatment. Stable brain metastases by this definition should be established prior to the first dose of trial treatment. Patients with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
• Prior treatment with any anti-programmed cell death 1, PD-L1, or programmed cell death ligand 2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against indoleamine 2, 3-dioxygenase, PD-L1, interleukin 2 receptor, or glucocorticoid-induced tumor necrosis factor receptor-related protein.

Sponsors & Collaborators

• Formycon AG: lead

Study Sites (13)

Formycon Investigative Site

Batumi, Georgia

Location

Formycon Investigative Site

Kutaisi, Georgia

Location

Formycon Investigative Site

Tbilisi, Georgia

Location

Formycon Investigative Site

George Town, Malaysia

Location

Formycon Investigative Site

Kuala Lumpur, Malaysia

Location

Formycon Investigative Site

Kuching, Malaysia

Location

Formycon Investigative Site

Shah Alam, Malaysia

Location

Formycon Investigative Site

Subang Jaya, Malaysia

Location

Formycon Investigative Site

Adana, Turkey (Türkiye)

Location

Formycon Investigative Site

Diyarbakır, Turkey (Türkiye)

Location

Formycon Investigative Site

Istanbul, Turkey (Türkiye)

Location

Formycon Investigative Site

Izmir, Turkey (Türkiye)

Location

Formycon Investigative Site

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 16, 2024
• Study Start: October 3, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5); MY (5); GE (3)