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A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

NCT ID: NCT06348199

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2026-09-30

Brief Summary

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The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:

• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.

Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SB27

SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Group Type EXPERIMENTAL

SB27

Intervention Type DRUG

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Keytruda

Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Group Type ACTIVE_COMPARATOR

Keytruda

Intervention Type DRUG

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Interventions

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SB27

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Intervention Type DRUG

Keytruda

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 18 years of age
* Have been diagnosed with stage IV non-squamous NSCLC
* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
* Agree to use adequate methods of contraception

Exclusion Criteria

* Unable or unwilling to take folic acid and vitamin B12 supplementation
* Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SB Investigative Site

Banja Luka, , Bosnia and Herzegovina

Site Status

SB Investigative Site

Mostar, , Bosnia and Herzegovina

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SB Investigative Site

Sarajevo, , Bosnia and Herzegovina

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SB Investigative Site

Curitiba, , Brazil

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SB Investigative Site

Florianópolis, , Brazil

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SB Investigative Site

Ijuí, , Brazil

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SB Investigative Site

Natal, , Brazil

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SB Investigative Site

Pelotas, , Brazil

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SB Investigative Site 1

Porto Alegre, , Brazil

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SB Investigative Site 2

Porto Alegre, , Brazil

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SB Investigative Site

Rio de Janeiro, , Brazil

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SB Investigative Site

Santo André, , Brazil

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SB Investigative Site

Batumi, , Georgia

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SB Investigative Site 1

Tbilisi, , Georgia

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SB Investigative Site 2

Tbilisi, , Georgia

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SB Investigative Site 3

Tbilisi, , Georgia

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SB Investigative Site 4

Tbilisi, , Georgia

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SB Investigative Site 5

Tbilisi, , Georgia

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SB Investigative Site 6

Tbilisi, , Georgia

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SB Investigative Site

Düsseldorf, , Germany

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SB Investigative Site

Halle, , Germany

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SB Investigative Site

Moers, , Germany

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SB Investigative Site

Neuss, , Germany

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SB Investigative Site

Bangalore, , India

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SB Investigative Site

Bhubaneshwar, , India

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SB Investigative Site

Bhubaneswar, , India

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SB Investigative Site

Erandwane, , India

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SB Investigative Site

Hyderabad, , India

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SB Investigative Site 1

Jaipur, , India

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SB Investigative Site 2

Jaipur, , India

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SB Investigative Site

Mumbai, , India

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SB Investigative Site

Sūrat, , India

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SB Investigative Site

Udaipur, , India

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SB Investigative Site

Himeji, , Japan

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SB Investigative Site

Iwakuni, , Japan

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SB Investigative Site

Izumi, , Japan

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SB Investigative Site

Kawachi-Nagano, , Japan

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SB Investigative Site

Kobe, , Japan

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SB Investigative Site

Kochi, , Japan

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SB Investigative Site

Sagamihara, , Japan

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SB Investigative Site

Tachikawa, , Japan

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SB Investigative Site

Takarazuka, , Japan

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SB Investigative Site

Toyonaka, , Japan

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SB Investigative Site

George Town, , Malaysia

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SB Investigative Site

Johor Bahru, , Malaysia

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SB Investigative Site

Kota Bharu, , Malaysia

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SB Investigative Site

Kuantan, , Malaysia

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SB Investigative Site

Lembah Pantai, , Malaysia

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SB Investigative Site

Putrajaya, , Malaysia

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SB Investigative Site

Aguascalientes, , Mexico

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SB Investigative Site

Guadalajara, , Mexico

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SB Investigative Site

Mexico City, , Mexico

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SB Investigative Site

Davao City, , Philippines

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SB Investigative Site

Makati City, , Philippines

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SB Investigative Site

Manila, , Philippines

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SB Investigative Site

Quezon City, , Philippines

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SB Investigative Site

San Juan City, , Philippines

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SB Investigative Site

Cluj-Napoca, , Romania

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SB Investigative Site 1

Craiova, , Romania

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SB Investigative Site 2

Craiova, , Romania

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SB Investigative Site

Craiova, , Romania

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SB Investigative Site

Iași, , Romania

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SB Investigative Site

Oradea, , Romania

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SB Investigative Site

Sibiu, , Romania

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SB Investigative Site

Suceava, , Romania

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SB Investigative Site 1

Belgrade, , Serbia

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SB Investigative Site 2

Belgrade, , Serbia

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SB Investigative Site

Kamenitz, , Serbia

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SB Investigative Site

Kragujevac, , Serbia

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SB Investigative Site

Niš, , Serbia

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SB Investigative Site

Leganés, , Spain

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SB Investigative Site

Málaga, , Spain

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SB Investigative Site

Ourense, , Spain

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SB Investigative Site

Oviedo, , Spain

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SB Investigative Site

Santiago de Compostela, , Spain

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SB Investigative Site

Seville, , Spain

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SB Investigative Site

Valencia, , Spain

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SB Investigative Site 1

Bangkok, , Thailand

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SB Investigative Site 2

Bangkok, , Thailand

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SB Investigative Site

Bangkok Noi, , Thailand

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SB Investigative Site

Khon Kaen, , Thailand

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SB Investigative Site

Adapazarı, , Turkey (Türkiye)

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SB Investigative Site 1

Ankara, , Turkey (Türkiye)

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SB Investigative Site 2

Ankara, , Turkey (Türkiye)

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SB Investigative Site

Bağcılar, , Turkey (Türkiye)

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SB Investigative Site

Balgat, , Turkey (Türkiye)

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SB Investigative Site

Çubuk, , Turkey (Türkiye)

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SB Investigative Site

Istanbul, , Turkey (Türkiye)

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SB Investigative Site

İzmit, , Turkey (Türkiye)

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SB Investigative Site

Kavaklıdere, , Turkey (Türkiye)

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SB Investigative Site

Konak, , Turkey (Türkiye)

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SB Investigative Site

Maltepe, , Turkey (Türkiye)

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SB Investigative Site

Seyhan, , Turkey (Türkiye)

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SB Investigative Site

Sivas, , Turkey (Türkiye)

Site Status

Countries

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Bosnia and Herzegovina Brazil Georgia Germany India Japan Malaysia Mexico Philippines Romania Serbia Spain Thailand Turkey (Türkiye)

Other Identifiers

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SB27-3004

Identifier Type: -

Identifier Source: org_study_id

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