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Clinical Trials List

Protocol NumberMK3475-671
NCT Number(ClinicalTrials.gov Identfier)NCT03425643
Active

2018-01-15 - 2029-06-30

Phase III

Recruiting4

Terminated1

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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

0 Recruiting

Audit

None

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 蔡鎮良 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

Audit

None

Principal Investigator 廖斌志 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 Terminated

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

Primary -To evaluate event-free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by blinded independent central review (BICR). -To evaluate the overall survival (OS). Secondary -To evaluate the rate of major pathological response (mPR) assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab. -To evaluate the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab. -To evaluate mean change from baseline in the neoadjuvant phase and in the adjuvant phase in global health status/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ)-C30. -To evaluate the safety and tolerability of NAC plus pembrolizumab followed by surgery and adjuvant pembrolizumab

Test Drug

Pembrolizumab (MK-3475) / 商品名：KEYTRUDA/吉舒達

Active Ingredient

Pembrolizumab (Humanized anti-PD-1 mAb)

Dosage Form

injection

Dosage

100 mg/ 4 mL

Endpoints

Primary Endpoint(s)
 Event-free survival (EFS)
 Overall survival (OS)
Secondary Endpoints
 Major pathological response (mPR) rate
 Pathological complete response (pCR) rate
 PRO outcome
 Safety and tolerability

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. Male/female participants who are at least 18 years of age on the day of
signing informed consent with previously untreated, histologically
confirmed NSCLC and histologically confirmed Stage IIB or IIIA NSCLC.
(AJCC Version 8). Lymph node disease requires histologic confirmation, while T3 (rib destruction) disease requires only radiographic
documentation.
2. Be able to undergo protocol therapy, including necessary surgery.
Male participants:
3. A male participant must agree to use contraception, as detailed in Protocol
Appendix 3: Contraceptive Guidance and Pregnancy Testing) for at least
180 days, (corresponding to time needed to eliminate any study
treatment(s) [pembrolizumab and or any active combination] plus an
additional 90 days [a spermatogenesis cycle] for study treatments where
there is risk of clinically relevant genotoxicity) after the last dose of study
treatment and refrain from donating sperm during this period.
4. Abstinence is acceptable if this is the usual lifestyle and preferred
contraception for the participant.
Female participants:
5. a.) A female participant is eligible to participate if she is not pregnant (see
Protocol Appendix 3: Contraceptive Guidance and Pregnancy Testing), not
breastfeeding, and at least one of the following conditions applies: a.) Not a
woman of childbearing potential (WOCBP) as defined in Protocol
Appendix 3: Contraceptive Guidance and Pregnancy Testing
OR
b.) A WOCBP who agrees to follow the contraceptive guidance in Protocol
Appendix 3: Contraceptive Guidance and Pregnancy Testing during the
treatment period and for at least 180 days (corresponding to time needed to
eliminate any study treatment(s) [pembrolizumab and or any active
combination] plus 30 days [a menstruation cycle] for study treatments with
risk of genotoxicity) after the last dose of study treatment.
Informed Consent
6. The participant (or legally acceptable representative if applicable) provides
written informed consent/assent for the trial.
Disease-state Specific criteria
7. Have available formalin-fixed paraffin embedded (FFPE) tumor tissue
sample blocks for submission. If blocks are not available, have unstained
slides for submission for central PD-L1 testing. See Procedures Manual for
further details.
8. Have an ECOG performance status of 0 to 1 within 10 days of
randomization.
9. Have adequate organ function. Specimens must be collected within 10 days prior to the start of trial treatment.

Exclusion Criteria

Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. A WOCBP who has a positive urine pregnancy test within 24 hours before
the first dose of study treatment (see Protocol Appendix 3). If the urine
test cannot be confirmed as negative, a serum pregnancy test is required.
In such cases, the participant must be excluded from participation if the
serum pregnancy result is positive.
2. Has one of the following tumor locations/types:
 NSCLC involving the superior sulcus
 Large cell neuro-endocrine cancer (LCNEC)
 Sarcomatoid tumor
3. Has a history of (non-infectious) pneumonitis /interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease that
requires steroids.
4. Has an active infection requiring systemic therapy.
5. Has had an allogenic tissue/sold organ transplant.
6. Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its
active substance and/or any of its excipients.
7. Has a known severe hypersensitivity (≥ Grade 3) to any of the study
chemotherapy agents and/or to any of their excipients.
8. 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.
9. Has a known history of human immunodeficiency virus (HIV) infection.
No HIV testing is required unless mandated by local health authority.
10. 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 and Hepatitis C is required unless
mandated by local health authority.
11. Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
12. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the participant’s participation for the full duration of the trial, or is not in the
best interest of the participant to participate, in the opinion of the treating
investigator.
13. Has known psychiatric or substance abuse disorders that would interfere
with cooperating with the requirements of the trial.
Prior/Concomitant Therapy
14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent or with an agent directed to another co-inhibitory T-cell receptor (eg,
CTLA-4, OX-40, CD137).
15. Has received prior systemic anti-cancer therapy including investigational
agents for the current malignancy prior to randomization/allocation.
Note: Must have recovered from all AEs due to previous therapies for other
medical conditions to ≤ Grade 1 or baseline. Residual ≤ Grade 2
neuropathy is acceptable.
Note: Must have recovered adequately from any previous surgical
procedure prior to starting trial treatment
16. Has received prior radiotherapy within 2 weeks of start of trial treatment.
Participants must have recovered from all radiation-related toxicities, not
require corticosteroids, and not have had radiation pneumonitis.
17. Has received a live vaccine within 30 days prior to the first dose of trial
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.
Prior/Concurrent Clinical Study Experience
18. Is currently participating in or has participated in a trial of an
investigational agent or has used an investigational device within 4 weeks
prior to the first dose of trial treatment.
Note: Participants who have entered the follow-up phase of an
investigational trial may participate as long as it has been 4 weeks after the
last dose of the previous investigational agent.
Diagnostic assessments
19. Has a diagnosis of immunodeficiency or is receiving systemic steroid
therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other
form of immunosuppressive therapy within 7 days prior the first dose of
trial drug.
20. Has a known additional malignancy that is progressing or requires active
treatment within the past (5 years).
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ
cervical cancer or breast carcinoma) that have undergone potentially
curative therapy are not excluded.
Other Exclusions
21. Is pregnant or breastfeeding or expecting to conceive or father children
within the projected duration of the trial, starting with the screening visit
through 180 days after the last dose of trial treatment.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    786 participants

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