Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Small Cell Lung Cancer
Спонсор: Merck Sharp & Dohme LLC
Налично на:
БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria:
1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
* Pembrolizumab: 120 days
* Olaparib: 7 days
Exclusion Criteria:
1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery \<4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.
Места на провеждане
25
Австралия (1)
Campbelltown Hospital ( Site 3002)
Campbelltown , New South Wales
Белгия (1)
Saint-Luc UCL ( Site 1005)
Brussels , Bruxelles-Capitale, Region de
България (1)
MHAT "Uni Hospital" OOD ( Site 2507)
Panagyurishte , Pazardzhik
Канада (1)
Cross Cancer Institute ( Site 0206)
Edmonton , Alberta
Китай (1)
Peking Union Medical College Hospital ( Site 3102)
Beijing , Beijing Municipality
Estonia (1)
SA Pohja-Eesti Regionaalhaigla ( Site 2201)
Tallinn , Harju
Франция (1)
C.H. de Saint Quentin ( Site 1111)
Saint-Quentin , Aisne
Гърция (1)
Henry Dunant Hospital ( Site 1205)
Athens , Attica
Унгария (1)
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)
Kecskemét , Bács-Kiskun county
Израел (1)
Rambam Health Care Campus-Oncology Division ( Site 1401)
Haifa
Италия (1)
A O U Policlinico di Modena ( Site 1503)
Modena , Emilia-Romagna
Япония (1)
Aichi Cancer Center ( Site 4010)
Nagoya , Aichi-ken
Lithuania (1)
Nacionalinis Vezio Institutas ( Site 2300)
Vilnius , Vilniaus Miestas
Mexico (1)
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)
Guadalajara , Jalisco
Португалия (1)
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1704)
Lisbon , Lisbon District
Румъния (1)
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)
Cluj-Napoca , Cluj
Russia (1)
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
Moscow , Moscow
Сърбия (1)
Institute for Oncology and Radiology of Serbia ( Site 2995)
Belgrade , Beograd
South Africa (1)
Steve Biko Academic Hospital ( Site 5000)
Pretoria , Gauteng
Южна Корея (1)
National Cancer Center ( Site 3306)
Goyang-si , Kyonggi-do
Испания (1)
Hospital Duran i Reynals ( Site 1903)
L'Hospitalet de Llobregat , Barcelona
Турция (1)
Ankara Bilkent Sehir Hastanesi ( Site 2007)
Ankara
Ukraine (1)
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)