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Clinical Trials List

Protocol NumberMK7339-006
NCT Number(ClinicalTrials.gov Identfier)NCT03976323
Active

2019-05-01 - 2026-12-31

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

    2026/03/01

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wu-Chou Su 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

Condition/Disease

Metastatic Nonsquamous Non-Small-Cell Lung Cancer

Objectives

Primary Objectives  Objective: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR).  Objective: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS). Secondary Objectives  Objective: To evaluate the safety and tolerability of pembrolizumab plus maintenance olaparib compared to pembrolizumab plus maintenance pemetrexed.  Objective: To evaluate the change from baseline (at randomization) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab plus maintenance olaparib compared with pembrolizumab plus pemetrexed.

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 Experiencing an Adverse Event (AE) [ 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 Treatment Due to Adverse Event (AE) [ 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 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 EORTC 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 EORTC 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.

Change from Baseline in EORTC 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 EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 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 is 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 EORTC QLQ-C30 Items 29 and 30 scale scores.

Time to True Deterioration (TTD) in 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 is 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 EORTC QLQ-LC13 cough (Item 1) scale score.

Time to True Deterioration (TTD) in EORTC (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 is 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 EORTC QLQ-LC13 chest pain (Item 10) scale score.

Time to True Deterioration (TTD) in EORTC 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 is 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 EORTC QLQ-C30 dyspnea (Item 8) scale score.

Time to True Deterioration (TTD) in EORTC 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 is 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 EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.

Inclution Criteria

1. Have a histologically confirmed or cytologically confirmed diagnosis of nonsquamous
NSCLC.
2. Have stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer
(AJCC) 8
th Edition) nonsquamous NSCLC.
3. Have confirmation that EGFR, ALK, or ROS1-directed therapy is not indicated
(documentation of absence of tumor-activating EGFR mutations AND absence of ALK
and ROS1 gene rearrangements, OR presence of a K-Ras mutation).
4. Have measurable disease, based on RECIST 1.1, as determined by the local site
investigator/radiology assessment. Lesions that appear measurable, but are situated in a
previously irradiated area, can be considered measurable (eligible for selection as target
lesions) if they have shown documented growth since the completion of radiation.
5. Have provided archival tumor tissue sample or newly obtained core or excisional 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.
6. Have a life expectancy of at least 3 months.
7. Have an ECOG performance score of 0 or 1 assessed within 7 days prior to the
administration of study intervention.
8. 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.
9. Have adequate organ function, as indicated by the following laboratory values (Table 3).
All screening laboratory tests should be performed within 10 days prior to the first dose
of study intervention.
10. Be at least 18 years of age at the time of signing the informed consent.
11. Male participants are eligible to participate if they agree to the following during the
intervention period and for at least 180 days after the last dose of study intervention:
 Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
(abstinent on a long-term and persistent basis) and agree to remain abstinent
OR
 Agree to use contraception, unless confirmed to be azoospermic (vasectomized or
secondary to medical cause [Appendix 5]), as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive
method when having penile-vaginal intercourse with a woman of childbearing
potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or
breastfeeding partner must agree to remain abstinent from penile-vaginal
intercourse or use a male condom during each episode of penile-vaginal
penetration.
12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and
at least 1 of the following conditions applies:
a) Is not a WOCBP
OR
- b) Is a WOCBP and using a contraceptive method that is highly effective (with a
failure rate of <1% per year), or be abstinent from heterosexual intercourse as their
preferred and usual lifestyle (abstinent on a long term and persistent basis), as
described in Appendix 5 during the intervention period and for at least 180 days after
the last dose of study intervention. The investigator should evaluate the potential for
contraceptive method failure (ie, noncompliance, recently initiated) in relationship to
the first dose of study intervention.
13. Have (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 study without
participating in future biomedical research.
14. Have a CR/PR or SD of their NSCLC after completion of the study-specified Induction
Phase, as determined by central imaging review.

Exclusion Criteria

1. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized
by the predominant cell type; if small cell elements are present, the participant is
ineligible.
2. Has a known additional malignancy that is progressing or has progressed within the past
3 years requiring active treatment.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the
skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have
undergone potentially curative therapy are not excluded.
3. Has known active central nervous system 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 severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
5. Participant has a known hypersensitivity to any components or excipients of cisplatin,
carboplatin, pemetrexed, or olaparib.
6. Has 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) is not considered a form of systemic
treatment and is allowed.
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 a 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 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. Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis).
13. Has symptomatic ascites or pleural effusion. A participant who is clinically stable
following treatment for these conditions (including therapeutic thoraco- or paracentesis)
is eligible.
14. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is
not exclusionary.
15. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features
suggestive of MDS/AML.
16. Before the first dose of study intervention:
a. Has received prior systemic cytotoxic chemotherapy for metastatic disease.
b. Has received antineoplastic biological 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.
17. Has received prior therapy with olaparib or with any other PARP inhibitor.
18. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose
of study intervention.
19. Is expected to require any other form of antineoplastic therapy while on study.
20. 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).
21. 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. Has received a live-virus vaccination within
30 days of planned treatment start. Seasonal influenza vaccines that do not contain live
virus are permitted.
22. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, other than an
aspirin dose ≤1.3 g per day, for a 5-day period (an 8-day period for long-acting agents,
such as piroxicam).
23. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
24. Received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF],
granulocyte-macrophage colony-stimulating factor or recombinant erythropoietin) within
28 days prior to the first dose of study intervention.
25. 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.
26. Is currently receiving either strong (eg, 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 (21 days) for other agents.
27. 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.
28. 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.
29. Is considered a poor medical risk, in the opinion of the treating investigator, due to a
serious, uncontrolled medical disorder or nonmalignant 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.
30. Has a known psychiatric or substance abuse disorder that would interfere with
cooperation with the requirements of the study.
31. 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.
32. Is unable to swallow orally administered medication, or has a gastrointestinal disorder
affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption).
33. Has had an allogenic-tissue/solid-organ transplant.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    1005 participants

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