Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

STATUS

Recruiting
End date

Jul 6, 2026
participants needed

870
sponsor

Merck Sharp & Dohme Corp.

Send

Updated on 19 February 2024

See if I qualify

cancer

immunomodulator

measurable disease

metastasis

carboplatin

pembrolizumab

lung cancer

pemetrexed

paclitaxel

durvalumab

targeted therapy

etoposide

chemoradiotherapy

pulmonary function tests

carcinoma

immunomodulators

olaparib

pulmonary function test

stage iv non-small cell lung cancer

stage iii non-small cell lung cancer

adjuvant therapy

concurrent chemoradiation

stage iv nsclc

chemoradiation therapy

adjuvant

non-small cell lung cancer

small cell lung cancer

cisplatin

lung neoplasms

lung neoplasm

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Pulmonary Disease, Lung Neoplasm, lung cancer, lung cancer
Age	18years - 120years
Treatment	Carboplatin, Pembrolizumab, Pemetrexed, Paclitaxel, Etoposide, Cisplatin, Durvalumab, Olaparib, Placebo for olaparib, Thoracic Radiotherapy
Clinical Study Identifier	NCT04380636
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Has pathologically (histologically or cytologically) confirmed NSCLC
	Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
	Is unable to undergo surgery with curative intent for Stage III NSCLC
	Has no evidence of metastatic disease indicating Stage IV NSCLC
	Has measurable disease as defined by RECIST 1.1
	Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC
	Has provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional])
	Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
	Has a life expectancy of at least 6 months
	A male participant must agree to use contraception and refrain from donating sperm during the treatment period and for at least 180 days following the last dose of study treatment
	A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least 180 days following the last dose of study treatment
	A female participant of child-bearing potential must have a negative highly sensitive pregnancy test (urine or serum) within 72 hours before the first dose of study treatment
	Has adequate pulmonary function tests
	Has adequate organ function
	Has provided written informed consent
Exclusion Criteria
	Has small cell lung cancer or a mixed tumor with presence of small cell elements
	Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
	Has had documented weight loss >10% (from baseline) in the preceding 3 months
	Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
	Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
	Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
	Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
	Is expected to require any other form of antineoplastic therapy, while on study
	Has received a live vaccine within 30 days prior to the first dose of study treatment
	Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
	Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
	Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
	Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose 1.3 grams per day, for at least 2 days before, during, and for at least 2 days after administration of pemetrexed
	Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
	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 treatment
	Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
	Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
	Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
	Has severe hypersensitivity (Grade 3) to study intervention and/or any of its excipients
	Has an active autoimmune disease that has required systemic treatment in past 2 years
	Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
	Has an active infection requiring systemic therapy
	Has a known history of human immunodeficiency virus (HIV) infection
	Has a known history of Hepatitis B or known active Hepatitis C virus infection
	Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
	Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
	Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
	Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
	Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
	Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment
	Has had an allogenic tissue/solid organ transplant

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Study Definition

Wikipedia

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)