問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMK-7339-008
NCT Number(ClinicalTrials.gov Identfier)NCT03976362

2019-05-01 - 2025-12-31

Phase III

Recruiting6

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

Primary • Objective: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to progression-free survival (PFS) assessed according to RECIST 1.1 (Section 4.2.1.1) by blinded independent central review (BICR). • Objective: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to overall survival (OS).

Test Drug

KEYTRUDA / Lynparza

Active Ingredient

Olaparib
pembrolizumab

Dosage Form

Injection
Film-coated Tablet

Dosage

100 mg/ 4 mL/ vial
100 mg; 150 mg

Endpoints

Primary Outcome Measures :
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 3 years ]
Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.

Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
Overall survival is the time from the date of randomization to death due to any cause.


Secondary Outcome Measures :
Number of Participants With One or More Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Number of participants discontinuing study intervention due to adverse events (AEs) [ Time Frame: Up to approximately 5 years ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome.

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Baseline (at randomization) and Week 18 post-randomization ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.

Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores.

Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score.

Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score.

Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score.

Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Up to approximately 5 years ]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.

Inclution Criteria

1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC. Patients with mixed histology (eg, adenosquamous) are allowed if there is squamous component
in the specimen.
2. Have stage IV (T any, N any, M1a, M1b, or M1c as per AJCC 8th edition) squamous NSCLC.
3. Have measurable disease based on RECIST 1.1, as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the
adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor
tissue submission can be found in the Procedures Manual).
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study
intervention.
7. Have a life expectancy of at least 3 months.
8. Has adequate organ function, as detailed in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study treatment.
9. Be ≥18 years of age on day of signing informed consent.
10. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 180 days following the last dose of
pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy.
11. A female participant is eligible to participate if she is not pregnant (Appendix 5), not breastfeeding, and at least 1 of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR
b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 180 days following the last dose of pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy.
12. Has (or legally acceptable representative if applicable) provided written informed consent/assent for the study. The participant may also provide consent/assent for Future
Biomedical Research. However, the participant may participate in the main trial without participating in Future Biomedical Research.
13. Has a CR/PR or stable disease of their NSCLC as determined by central imaging review after completion of study-specified Induction Phase.

Exclusion Criteria

1. Has non-squamous histology NSCLC. Mixed tumors will be categorized by the
predominant cell type; if small cell elements are present, the participant is ineligible; for
non-small cell histology if there is any squamous element is present (example
adenosquamous), the participant is eligible; the squamous element does not have to be
predominant.
2. Has a known additional malignancy that is progressing or has progressed within the past
3 years requiring active treatment.
3. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they are clinically stable for at least 2 weeks and, have no evidence of new or
enlarging brain metastases and also are off steroids 3 days prior to dosing with study
medication. Stable brain metastases by this definition should be established prior to the
first dose of study medication. Participants with known untreated, asymptomatic brain
metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or
minimal surrounding edema, and no lesion >1.5 cm) may participate but will require
regular imaging of the brain as a site of disease.
4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel
or nab-paclitaxel, or olaparib.
5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
6. Has an active autoimmune disease that has required systemic treatment in past 2 years
(ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment.
7. 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.
8. Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
9. Has an active infection requiring systemic therapy.
10. Has known history of human immunodeficiency virus (HIV) infection. No HIV testing is
required unless mandated by local health authority.
11. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.
Note: No testing for Hepatitis B or Hepatitis C is required unless mandated by local
health authority.
12. Participant has a known history of active tuberculosis (TB, Mycobacterium tuberculosis).
13. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is
not exclusionary.
14. Has symptomatic ascites or pleural effusion. A participant who is clinically stable
following treatment for these conditions (including therapeutic thoraco- or paracentesis)
is eligible.
15. Has a known psychiatric or substance abuse disorder that would interfere with the
participant’s ability to cooperate with the requirements of the study.
16. 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 intervention.
17. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features
suggestive of MDS/AML.
18. Has received colony-stimulating factors (eg, 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 intervention.
19. Is considered a poor medical risk in the opinion of the treating Investigator due to a
serious, uncontrolled medical disorder or non-malignant systemic disease. Examples
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within
3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal
cord compression, or superior vena cava syndrome. .
20. Is unable to swallow orally administered medication or has a gastrointestinal disorder
affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
21. Has received prior therapy with olaparib or with any other PARP inhibitor.
22. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an
agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4,
OX-40, CD137).
23. Before the first dose of study treatment:
a) Has received prior systemic cytotoxic chemotherapy for metastatic disease
b) Has received other targeted or biological antineoplastic therapy (eg, erlotinib,
crizotinib, cetuximab) for metastatic disease
c) Had major surgery (<3 weeks prior to study intervention) or has not recovered
from any effects of any major surgery.
24. Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of
trial treatment.
25. Completed palliative radiotherapy within 7 days of the first dose of trial treatment.
Participants must have recovered from all radiation-related toxicities and not require
corticosteroids
26. Is expected to require any other form of antineoplastic therapy while on study.
27. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples
of live vaccines include, but are not limited to, the following: measles, mumps, rubella,
varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG),
and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus
vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live
attenuated vaccines and are not allowed.
28. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin,
rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate (eg,
bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the
duration of the study. The required washout period prior to starting olaparib is 5 weeks
for phenobarbital and 3 weeks for other agents.
29. 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. The required washout period prior to starting
olaparib is 2 weeks.
30. 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.
31. Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible
cardiac conditions, as judged by the Investigator (eg, unstable ischemia, uncontrolled
symptomatic arrhythmia, congestive heart failure, electrolyte disturbances, etc.), or
participant has congenital long QT syndrome.
32. Has had an allogenic tissue/solid organ transplant.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    857 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB