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New drug targets lung cancer protein, aims to shrink tumors and extend life

NCT ID NCT07099898

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a new medicine called Risvutatug rezetecan (Ris-Rez) that targets a specific protein (B7-H3) on cancer cells to stop their growth. It is for adults with relapsed small cell lung cancer who have already tried one prior treatment. About 420 participants will be randomly assigned to receive either Ris-Rez or the standard drug topotecan, and researchers will compare how well each shrinks tumors and helps people live longer, while also checking side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Adults \>18 or the minimum legal adult age at the time the informed consent form is signed * Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible. * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. * Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol. * Has adequate organ function and an ECOG performance status of 0 or 1 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Pathological diagnosis of complex SCLC or transformed SCLC. * Limited stage small cell lung cancer at diagnosis * Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3. * Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. * Has severe, uncontrolled or active cardiovascular disorders. * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV). * Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. * Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids. * Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease), * Has active Hepatitis B or Hepatitis C

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Conditions

The condition(s) this trial relates to.

lung neoplasm small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms, lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    130 sites in 25 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

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    Wilson, North Carolina, 27893, United States

  • GSK Investigational Site

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    Mar del Plata, Buenos Aires, 7600, Argentina

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    Buenos Aires, C1426ABP, Argentina

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    Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

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    Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

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    Rosario, S2000 DEJ, Argentina

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    Vicente López, 1602, Argentina

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    Blacktown, New South Wales, 2148, Australia

  • GSK Investigational Site

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    St Leonards, New South Wales, 2065, Australia

  • GSK Investigational Site

    WITHDRAWN

    Nedlands, Western Australia, 6009, Australia

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    Barretos, 14784-400, Brazil

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    CuritibaPR, 80810-050, Brazil

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    Florianópolis, 88020-210, Brazil

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    Porto Alegre, 90020-090, Brazil

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    Porto Alegre, 90610-000, Brazil

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    Rio de Janeiro, 22250-905, Brazil

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    São Paulo, 04312903, Brazil

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    Pleven, 5800, Bulgaria

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    Plovdiv, Bulgaria

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    Rousse, 7002, Bulgaria

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    Sofia, 1606, Bulgaria

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    Sofia, 1632, Bulgaria

  • GSK Investigational Site

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    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

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    Toronto, Ontario, M5G 1Z5, Canada

  • GSK Investigational Site

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    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

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    Montreal, Quebec, H4J 1C5, Canada

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    Vaasa, 65130, Finland

  • GSK Investigational Site

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    Boulogne-Billancourt, 92100, France

  • GSK Investigational Site

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    Grenoble, 38043, France

  • GSK Investigational Site

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    Saint-Herblain, 44805, France

  • GSK Investigational Site

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    Karlsruhe, Baden-Wurttemberg, 76137, Germany

  • GSK Investigational Site

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    Augsburg, 86156, Germany

  • GSK Investigational Site

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    Chemnitz, 09113, Germany

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    Esslingen am Neckar, 73730, Germany

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    Heidelberg, 69126, Germany

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    Löwenstein, 74245, Germany

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    Lübeck, 23562, Germany

  • GSK Investigational Site

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    München, 81377, Germany

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    Nuremberg, 90340, Germany

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    Stuttgart, 70376, Germany

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    Athens, 115 22, Greece

  • GSK Investigational Site

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    Athens, 11526, Greece

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    Athens, 12462, Greece

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    Heraklion, 71110, Greece

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    Pylaia Thessaloniki, 570 01, Greece

  • GSK Investigational Site

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    Pylaia Thessaloniki, 57001, Greece

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    Budapest, H-1121, Hungary

  • GSK Investigational Site

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    Farkasgyepű, 8552, Hungary

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    Gyöngyös, 3200, Hungary

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    Kecskemét, 6000, Hungary

  • GSK Investigational Site

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    Székesfehérvár, 8000, Hungary

  • GSK Investigational Site

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    Törökbálint, 2045, Hungary

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    Dublin, D09 V2N0, Ireland

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    Jerusalem, 9112001, Israel

  • GSK Investigational Site

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    Tel Aviv, 6423906, Israel

  • GSK Investigational Site

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    Bergamo, Italy

  • GSK Investigational Site

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    Genova, 16132, Italy

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    Milan, 20141, Italy

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    Orbassano, 10043, Italy

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    Pisa, 57124, Italy

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    Siena, 53100, Italy

  • GSK Investigational Site

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    Verona, 37134, Italy

  • GSK Investigational Site

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    Fukuoka, 812-8582, Japan

  • GSK Investigational Site

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    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

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    Ishikawa, 920-8530, Japan

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    Kagoshima, 890-8520, Japan

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    Kanagawa, 241-8515, Japan

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    Kanagawa, 252-0375, Japan

  • GSK Investigational Site

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    Kochi, 783-8505, Japan

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    Kyoto, 612-8555, Japan

  • GSK Investigational Site

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    Mie, 515-8544, Japan

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    Miyagi, 980-8574, Japan

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    Osaka, 541-8567, Japan

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    Osaka, 573-1191, Japan

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    Osaka, 594-0073, Japan

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    Tokyo, 104-0045, Japan

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    Tokyo, 113-8603, Japan

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    Tokyo, 113-8677, Japan

  • GSK Investigational Site

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    Toyama, 930-8550, Japan

  • GSK Investigational Site

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    San Pedro Garza García, Nuevo León, 66260, Mexico

  • GSK Investigational Site

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    Guadajalara, 44280, Mexico

  • GSK Investigational Site

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    Mexico City, 06700, Mexico

  • GSK Investigational Site

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    Mexico City, 06760, Mexico

  • GSK Investigational Site

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    Gliwice, 44-102, Poland

  • GSK Investigational Site

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    Kielce, 25-640, Poland

  • GSK Investigational Site

    WITHDRAWN

    Lodz, 93-338, Poland

  • GSK Investigational Site

    RECRUITING

    Otwock, 05-400, Poland

  • GSK Investigational Site

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    Poznan, 60-569, Poland

  • GSK Investigational Site

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    Siedlce, 08-110, Poland

  • GSK Investigational Site

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    Almada, 2805-267, Portugal

  • GSK Investigational Site

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    Guimarães, 4835-044, Portugal

  • GSK Investigational Site

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    Lisbon, 1400-038, Portugal

  • GSK Investigational Site

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    Craiova Dolj, Dolj, 200535, Romania

  • GSK Investigational Site

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    Cluj-Napoca, 400015, Romania

  • GSK Investigational Site

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    Craiova, 200542, Romania

  • GSK Investigational Site

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    Floreşti, 407280, Romania

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    Iași, 700451, Romania

  • GSK Investigational Site

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    Timișoara, 300329, Romania

  • GSK Investigational Site

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    Changwon, 51472, South Korea

  • GSK Investigational Site

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    Cheongju Chungcheongbuk-do, 28644, South Korea

  • GSK Investigational Site

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    Daegu, 41404, South Korea

  • GSK Investigational Site

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    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

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    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

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    Seoul, 03722, South Korea

  • GSK Investigational Site

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    Suwon Gyeonggi-do, 442723, South Korea

  • GSK Investigational Site

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    Ulsan, 44033, South Korea

  • GSK Investigational Site

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    Barcelona, 08035, Spain

  • GSK Investigational Site

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    Barcelona, 8017, Spain

  • GSK Investigational Site

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    Barcelona, 8036, Spain

  • GSK Investigational Site

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    L'Hospitalet de Llobrega, 08908, Spain

  • GSK Investigational Site

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    Las Palmas de Gran Canar, 35016, Spain

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    Madrid, 28007, Spain

  • GSK Investigational Site

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    Madrid, 28034, Spain

  • GSK Investigational Site

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    Madrid, 28041, Spain

  • GSK Investigational Site

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    Madrid, 28046, Spain

  • GSK Investigational Site

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    Santander, 39011, Spain

  • GSK Investigational Site

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    Stockholm, 171 64, Sweden

  • GSK Investigational Site

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    Basel, 4031, Switzerland

  • GSK Investigational Site

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    Lausanne, 1011, Switzerland

  • GSK Investigational Site

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    Adana, Adana, 01140, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • GSK Investigational Site

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    Ankara, 06010, Turkey (Türkiye)

  • GSK Investigational Site

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    Ankara, 06100, Turkey (Türkiye)

  • GSK Investigational Site

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    Ankara, 06520, Turkey (Türkiye)

  • GSK Investigational Site

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    Diyarbakır, 21280, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Izmir, 35110, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Izmir, 35340, Turkey (Türkiye)

  • GSK Investigational Site

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    London, W1G 6AD, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Portsmouth, PO6 3LY, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Truro, TR1 3LJ, United Kingdom

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