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 (LOTUS)

Conditions

NSCLC

Brief summary

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

Detailed description

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., *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., 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., 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.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGFYB206

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Measured as the proportion of participants whose cancer resolves completely or partially after approximately 9 months (40 weeks) from the start of treatment	—

Secondary

Measure	Time frame
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., *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., 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., Measured as the lowest amounts of the	—

Measure

Time frame

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., *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., 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., Measured as the lowest amounts of the

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Countries

Bulgaria, Poland, Romania

Outcome results

None listed