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Clinical Trials List

Protocol NumberMK-3475-789
NCT Number(ClinicalTrials.gov Identfier)NCT03515837

2018-05-01 - 2023-09-30

Phase III

Recruiting1

Terminated13

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

  • 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 Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Terminated

Audit

None

Principal Investigator Shang-Yin Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蘇健 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jih-Hsiang Lee Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林智斌 無
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃俊耀 無
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

CRO

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

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

None

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 Terminated

Audit

None

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer

Objectives

To compare PFS per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based on blinded independent central review (BICR) of the combinations of pembrolizumab + chemotherapy versus saline placebo + chemotherapy. To compare overall survival (OS) of the combinations of pembrolizumab + chemotherapy versus saline placebo + chemotherapy.

Test Drug

Keytruda injection

Active Ingredient

Pembrolizumab

Dosage Form

injection

Dosage

100

Endpoints

 Progression-free survival (PFS) is the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
 OS is defined as the time from randomization to death due to any cause.

Inclution Criteria

Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Type of Participant and Disease Characteristics
1. Have histologically or cytologically confirmed diagnosis of Stage IV (AJCC Version 8 or current
version as applicable) non-squamous NSCLC.
2. Have documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R.
3. Have investigator determined radiographic disease progression per RECIST 1.1 after treatment with
an EGFR TKI therapy:
a) Participants previously treated with 1st or 2nd generation EGFR TKI (eg,
erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR
T790M mutation. Note: Participants with negative EGFR T790M mutation using plasma
specimens will be required to have tissue biopsy confirmation of negative T790M mutation
prior to enrollment/confirmation of eligibility.
b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI
(eg, erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior
to enrollment. Note: Participants must have documentation of acquired T790M mutation
(using plasma or tissue biopsy specimens) after 1st disease progression prior to osimertinib
treatment.
c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible
regardless of their EGFR T790M mutation status.
Note: TKI washout for all participants is 1 week or 2 half-lives after last treatment dose, whichever
is longer.
Note: The site’s study team must have reviewed pre-trial images that are of diagnostic quality from
at least 2 dates to determine that radiographic progression has occurred per RECIST 1.1 following
initiation of the EGFR TKI. The central imaging vendor must have received these scans and have
confirmed that they are of acceptable diagnostic quality prior to randomization in this trial for a
possible retrospective analysis of this eligibility criterion. The central vendor will not be confirming
eligibility prior to randomization.
4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
Lesions situated in a previously irradiated area are considered measurable if progression has been
demonstrated in such lesions.
5. Have provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since
biopsy) 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 archival tissue.
Note: If site is sending unstained slides, we strongly recommend that sites freshly cut sections and
send out to the pathology laboratory within 7 days from sectioning in order for samples to be
received within 14 days of site slide-cutting date.
Demographics
6. Be ≥18 years of age on the day of signing informed consent.
7. Have a life expectancy of at least 3 months.
8. Have an ECOG performance status of 0 or 1 within 7 days prior to the first dose of study treatment
but before randomization.
Male participants:
9. A male participant must agree to use contraception as detailed in Section 10.3 of this protocol
during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to
180 days after last dose of chemotherapeutic agents.
Female participants:
10. A female participant is eligible to participate if she is not pregnant (see Section 10.3), not
breastfeeding, and at least one of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
OR
b. A WOCBP who agrees to follow the contraceptive guidance in Section 10.3 during the treatment
period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after the
last dose of chemotherapeutic agents.
Informed Consent
11. The participant provides written informed consent for the study.
12. Have adequate organ function as defined in the following table (Table 1). Specimens must be
collected within 10 days prior to the start of study treatment.

Exclusion Criteria

Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
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 symptomatic ascites or pleural effusion. A participant who is clinically stable following
treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see
Section 10.3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
will be required.
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first
dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication
Prior/Concomitant Therapy
4. 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).
5. Has received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR
TKIs, for metastatic NSCLC.
Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is
allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic
NSCLC.
Note: If participant received major surgery, they must have recovered adequately from the toxicity
and/or complications from the intervention prior to starting study treatment.
Note: Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at
least 4 weeks prior to the first dose of study treatment.
6. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have
recovered from all radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of
radiotherapy) to non-central nervous system (CNS) disease.
7. Has received a live vaccine within 30 days prior to the first dose of study treatment. 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.
Prior/Concurrent Clinical Study Experience
8. 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.
Note: Participants who have entered the follow-up phase of an investigational study may
participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Diagnostic Assessments
9. 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 treatment.
10. 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 (eg, breast carcinoma, cervical cancer in situ) that
have undergone potentially curative therapy are not excluded.
11. Has known active untreated CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically stable, ie,
without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging
should be performed during study screening), clinically stable and without requirement of steroid
treatment for at least 14 days prior to first dose of study treatment.
12. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
13. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
14. 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) is not considered a form of systemic treatment and is allowed.
15. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
16. Has an active infection requiring systemic therapy.
17. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is
required unless mandated by local health authority.
18. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive or
HBV-DNA detected) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected or HCV antibody reactive, if HCV-RNA is not the local SOC) infection.
Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health
authority.
19. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
20. 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.
21. Has known psychiatric or substance abuse disorder that would interfere with cooperating with the
requirements of the study.
Other Exclusions
22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study,
starting with the screening visit through 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents.

The Estimated Number of Participants

  • Taiwan

    56 participants

  • Global

    480 participants

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