A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

Samsung

Status and phase: Enrolling; Phase 1

Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage IIIA

Treatments: Drug: EU sourced Keytruda; Drug: US sourced Keytruda; Drug: SB27

Study type: Interventional

Funder types: Industry

Identifiers

NCT06268613

SB27-1005

Details and patient eligibility

About

The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:

• What the body does to the study drug, which is called "pharmacokinetic"

Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.

Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 years or older
• Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
• Have completely removed all of the cancer from the body surgically
• Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery

Exclusion criteria

• Have received anti-cancer therapy before surgery
• Have or had autoimmune disease in past 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups

SB27

Experimental group

Description:

SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Treatment:

Drug: SB27

EU sourced Keytruda

Active Comparator group

Description:

EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Treatment:

Drug: EU sourced Keytruda

US sourced Keytruda

Active Comparator group

Description:

EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Treatment:

Drug: US sourced Keytruda