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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Formycon AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

completed 19 Feb 2025

Decision date (initial)

2024-08-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To demonstrate the comparable effectiveness of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC

Secondary objectives 4

1. To compare the efficacy of FYB206 compared to Keytruda based on further clinical endpoints during Part 1.
2. To compare the safety of FYB206 with Keytruda during Part 1.
3. To compare how FYB206 and Keytruda affect the immune response of participants during Part 1.
4. To find and compare the amount of FYB206 and Keytruda in the blood after treatment for Part 1 of the trial.

Conditions and MedDRA coding

NSCLC

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
2. 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.
3. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. 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.

Exclusion criteria 4

1. Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
2. Known one of the mutations listed below: o ROS1 fusion gene o BRAF-V600E o RET fusion o MET Exon 14
3. 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.
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Measured as the proportion of participants whose cancer resolves completely or partially after approximately 9 months (40 weeks) from the start of treatment

Secondary endpoints 4

1. Measured as: proportion of participants (1) whose cancer resolves completely or partially at prespecified timepoints during the first year, (2) without disease progression* or death after one year. (3) alive after one year, (4) time for cancer to resolve completely or partially, (5) time from cancer resolving completely or partially until disease progression.
2. *Disease progression means significant tumor growth compared to the previous measurement. Identify and monitor the side effects, vital signs, oxygen levels, laboratory test results, and other health indicators that change during the study during the first year of treatment.
3. Number of participants who develop antibodies against the treatments when assessed at pre-decided timepoints. ‘Antibodies’ helps protect the body against foreign matter, such as bacteria and viruses or allergens. Sometimes, the body identifies some drugs or treatments as foreign matter and makes antibodies to fight them.
4. Measured as the lowest amounts of the drug 1 hour before the next dose was given, at various points during the first year of treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Formycon AG

Sponsor organisation

Formycon AG

Address

Fraunhoferstrasse 15, Martinsried Martinsried

City

Planegg

Postcode

82152

Country

Germany

Scientific contact point

Organisation

Formycon AG

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Formycon AG

Contact name

Clinical Trial Information Desk

Third parties 4

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications