Non Small Cell Lung CancerPhase 3LotusNCT06643117
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)
A Phase 3 study testing FYB206 and Keytruda in people with Non Small Cell Lung Cancer and Non-Squamous Non-Small Cell Lung Cancer, run by Formycon AG at 13 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- FYB206 and Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 3 Oct 2024to 13 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Malaysia5 sites
Formycon Investigative Site
George Town
Formycon Investigative Site
Kuala Lumpur
Formycon Investigative Site
Kuching
Formycon Investigative Site
Shah Alam
Formycon Investigative Site
Subang Jaya
Turkey (Türkiye)5 sites
Formycon Investigative Site
Adana
Formycon Investigative Site
Diyarbakır
Formycon Investigative Site
Istanbul
Formycon Investigative Site
Izmir
Formycon Investigative Site
Samsun
Georgia3 sites
Formycon Investigative Site
Batumi
Formycon Investigative Site
Kutaisi
Formycon Investigative Site
Tbilisi
About this study
Official title: A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on to Chemotherapy in Treatment-naïve Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
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.
- Being tested
- FYB206, Keytruda
- Keywords
- pembrolizumab, biosimilar, lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYB206Biological
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)
FYB206Biological
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)
KeytrudaBiological
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 group | Role | What they receive |
|---|---|---|
| FYB206 | Experimental | Not described Receives: Biological: FYB206 |
| Keytruda | Active comparator | Not described Receives: Biological: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start3 Oct 2024
- Primary completion13 May 2025
- Study completion13 May 2025
Why it stopped: Formycon concluded that continuing the trial is no longer necessary for the development and approval of FYB206. The therapeutic comparability of FYB206 to Keytruda can be demonstrated based on comprehensive analytical and PK comparability data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Formycon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643117
- Sponsor's protocol ID
- FYB206-C3-02
- Other IDs
- 2023-509766-37-00, 2023
- Acronym
- Lotus
- Status last verified
- Jun 2025
- First submitted
- 13 Oct 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on to Chemotherapy in Treatment-naïve Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06643117
- Acronym / sponsor ID
- Lotus / FYB206-C3-02
- Keywords
- pembrolizumab, biosimilar, lung cancer, NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Formycon concluded that continuing the trial is no longer necessary for the development and approval of FYB206. The therapeutic comparability of FYB206 to Keytruda can be demonstrated based on comprehensive analytical and PK comparability data
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Formycon AGIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FYB206 | Experimental | Biological: FYB206 |
| Keytruda | Active comparator | Biological: Keytruda |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FYB206FYB206 (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) | Biological | FYB206 |
| FYB206Open-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) | Biological | FYB206 |
| KeytrudaKeytruda (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) | Biological | Keytruda |
Primary outcome
Best objective response rate
Time frame: 40 Weeks
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
Results and safety
The study was stopped early (reason given: Formycon concluded that continuing the trial is no longer necessary for the development and approval of FYB206. The therapeutic comparability of FYB206 to Keytruda can be demonstrated based on comprehensive analytical and PK comparability data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FYB206 and Keytruda in people with Non Small Cell Lung Cancer and Non-Squamous Non-Small Cell Lung Cancer, run by Formycon AG at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Malaysia, Turkey (Türkiye), Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Formycon concluded that continuing the trial is no longer necessary for the development and approval of FYB206. The therapeutic comparability of FYB206 to Keytruda can be demonstrated based on comprehensive analytical and PK comparability data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best objective response rate (time frame: 40 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.