BridgeMD
A trial to show the similarity in effects, safety and immune response of FYB206 compared to Keytruda in people with metastatic non-squamous non-small cell lung cancer (NSCLC)
EU CTIS ID: 2023-509766-37-00
What this study is testing
To demonstrate the comparable effectiveness of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
- 3. 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.
- 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 2. Confirmation that EGFR or ALK--directed therapy is not indicated (ie, documentation of absence of tumor--activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements). Note if patient does not have documented genetic test results for EGFR and ALK available at the moment of ICF signature, it will be performed during screening locally.
You likely can't join 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: o ROS1 fusion gene o BRAF-V600E o RET fusion o 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.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Philippines
- Malaysia
- Georgia
- Serbia
- Turkey
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Philippines; Malaysia; Georgia; Serbia; Turkey and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.