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Be Part of Research - Trial Details - Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-NaĂŻve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
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Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-NaĂŻve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Aberdeen Dundee Taunton London London Manchester

Medical Conditions

Lung Neoplasms
Small Cell Lung Carcinoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2020 Oct 2027

Publications

"Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29."; "35613997"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab 200 mg Q3W

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab 400 mg Q6W

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;

Intervention Type : DRUG
Intervention Description : Pembrolizumab placebo (saline) Q3W

Intervention Arm Group : Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : DRUG
Intervention Description : Pembrolizumab placebo (saline) Q6W

Intervention Arm Group : Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : DRUG
Intervention Description : Olaparib 300 mg twice daily (BID)

Intervention Arm Group : Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;

Intervention Type : DRUG
Intervention Description : Olaparib matching placebo BID

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : DRUG
Intervention Description : Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : DRUG
Intervention Description : Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : RADIATION
Intervention Description : Standard Thoracic Radiotherapy

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;Group C (Pembrolizumab and Olaparib Matching Placebos);

Intervention Type : RADIATION
Intervention Description : PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Intervention Arm Group : Group A - Pembrolizumab 200 mg;Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID;Group C (Pembrolizumab and Olaparib Matching Placebos);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Infirmary Aberdeen ( Site 2403)
    Aberdeen
    Aberdeen City
    AB25 2ZN
  • Ninewells Hospital and Medical School ( Site 2401)
    Dundee
    Dundee City
    DD1 9SY
  • Taunton and Somerset Hospital ( Site 2404)
    Taunton
    England
    TA1 5DA
  • Barts Health NHS Trust ( Site 2409)
    London
    London, City Of
    EC1A 7BE
  • Guy s & St Thomas NHS Foundation Trust ( Site 2408)
    London
    London, City Of
    SE1 9RT
  • The Christie NHS Foundation Trust ( Site 2405)
    Manchester
    M20 4GJ


The study is sponsored by Merck Sharp & Dohme LLC



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Read full details for Trial ID: NCT04624204
Last updated 12 August 2024

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