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Clinical Trials List

Protocol NumberMK-7684A-007
NCT Number(ClinicalTrials.gov Identfier)NCT05226598
Active

2022-02-01 - 2028-09-30

Phase III

Recruiting5

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A Randomized, Double-Blind, Phase 3 Study of MK-7684A Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 Chun-Hui Lee Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

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 Chih-Hsi Kuo Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Non-Small Cell Lung Cancer

Objectives

Primary Objective: ‧To compare MK-7684A in combination with chemotherapy to Pembrolizumab in combination with chemotherapy with respect to progressionfree survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) ‧ To compare MK-7684A in combination with chemotherapy to Pembrolizumab in combination with chemotherapy with respect to Overall Survival (OS) Secondary objective: ‧To evaluate MK-7684A in combination with chemotherapy to Pembrolizumab in combination with chemotherapy with respect to Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR. ‧To evaluate the mean change from baseline in global health status/quality of life (QoL), physical functioning, dyspnea, cough, and chest pain for MK7684A in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy ‧To evaluate the Time to True Deterioration (TTD) in global health status/QoL, physical functioning, dyspnea, cough, and chest pain for MK-7684A in combination with chemotherapy compared to Pembrolizumab in combination with chemotherapy • To evaluate the safety and tolerability of MK-7684A in combination with chemotherapy compared to Pembrolizumab •To evaluate DOR per RECIST 1.1 as assessed by BICR for MK-7684A plus chemotherapy compared to Pembrolizumab plus chemotherapy

Test Drug

KeytrudaR injection

Active Ingredient

MK-7684 (vibostolimab)與MK-3475 (pembrolizumab)複方藥物
Pembrolizumab

Dosage Form

Injection
Injection

Dosage

MK-7684 200 mg and pembrolizumab 200 mg/20 mL
100 mg/4 mL

Endpoints

‧PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
‧ OS is defined as the time from randomization to the date of death due to any cause.

Inclution Criteria

Type of Participant and Disease Characteristics
1. Has a histologically or cytologically confirmed diagnosis of Stage IV (T any, N any,
M1a, M1b, M1c - AJCC eighth Edition) squamous or nonsquamous NSCLC.
Note: Mixed tumors will be characterized by the predominant cell type; if small cell
elements are present, the participant is ineligible.
2. Has measurable disease based on RECIST 1.1, as determined by the local site
assessment.
Note: Measurable disease is defined as having at least 1 measurable lesion by CT or MRI
per RECIST 1.1. 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.
3. Has provided tumor tissue (post diagnosis of metastatic disease is preferred) for
determination of PD-L1 status before randomization.
Note: Assessment of PD-L1 expression must be made from provided archival tumor
tissue sample or newly obtained core or incisional or excisional biopsy of a tumor lesion
not previously irradiated. FFPE tissue blocks are preferred to slides. Details pertaining to
tumor tissue submission can be found in the Laboratory Manual.
4. Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as
primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg,
DEL19 or L858R], AND absence of ALK and ROS1 gene rearrangements).
Note: If participant’s tumor is known to have a predominantly squamous histology,
molecular testing for EGFR mutation and ALK and ROS1 translocations will not be
required, as this is not part of current diagnostic guidelines.
5. Has not received prior systemic treatment for metastatic NSCLC.
Demographics
6. Is male or female, from ≥18 years of age inclusive, at the time of signing the informed
consent.
7. Has an ECOG PS of 0 or 1 assessed within 7 days before randomization.
8. Has a life expectancy of at least 3 months.
Male Participants
9. If male, agrees to the following during the intervention period and for at least the time
needed to eliminate each study intervention after the last dose of study intervention. The
length of time required to continue contraception for each study intervention is as
follows:
• Chemotherapy: at least 95 days from the last dose
• Refrain from donating sperm
PLUS either:
• Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on
a long-term and persistent basis) and agrees to remain abstinent
OR
• Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to
medical cause, documented from the site personnel’s review of the participant’s medical
records, medical examination, or medical history interview as detailed below:
- Uses a male condom plus partner use of an additional contraceptive method when
having penile-vaginal intercourse with a 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 penilevaginal penetration.
- Contraceptive use by men should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies. If the
contraception requirements in the local label for any of the study interventions is
more stringent than the requirements above, the local label requirements are to be
followed.
Female Participants
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and
at least one of the following conditions applies:
• Not a WOCBP
OR
• Is a WOCBP and:
- Uses a contraceptive method that is highly effective (with a failure rate of <1% per
year), with low user dependency, 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 the time
needed to eliminate each study intervention after the last dose of study intervention
and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use
for the purpose of reproduction during this period. The length of time required to
continue contraception for each study intervention is as follows:
◦ MK-7684A/pembrolizumab: 120 days
◦ Chemotherapy: 180 days
- The investigator should evaluate the potential for contraceptive method failure (ie,
noncompliance, recently initiated) in relationship to the first dose of study
intervention. Contraceptive use by women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies. If
the contraception requirements in the local label for any of the study interventions is
more stringent than the requirements above, the local label requirements are to be
followed.
- Has a negative highly sensitive pregnancy test ( as required by local regulations)
within 24 hours for urine or within 72 hours for serum before the first dose of study
intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result),
a serum pregnancy test is required. In such cases, the participant must be excluded
from participation if the serum pregnancy result is positive. Additional requirements
for pregnancy testing during and after study intervention are in Section 8.3.5.
- Abstains from breastfeeding during the study intervention period and for at least
120 days after the last dose of study intervention.
- Medical history, menstrual history, and recent sexual activity has been reviewed by
the investigator to decrease the risk for inclusion of a woman with an early undetected
pregnancy.
Informed Consent
11. The participant (or legally acceptable representative) has provided documented informed
consent/assent for the study. The participant may also provide consent/assent for FBR.
However, the participant may participate in the study without participating in FBR.
Additional Categories
12. Has adequate organ function as defined in Table 4. Specimens must be collected
within 10 days before the start of study intervention

Exclusion Criteria

Medical Conditions
1. Known additional malignancy that is progressing or has required active treatment within
the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have
undergone potentially curative therapy are not excluded.
2. Known active 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 as confirmed by repeat
imaging performed during study screening, are clinically stable and have not required
steroid treatment for at least 14 days before the first dose of study intervention.
Participants with asymptomatic brain metastases (ie, no neurological symptoms, no
requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5
cm) may participate.
3. Severe hypersensitivity (≥Grade 3) to MK-7684, MK-7684A, pembrolizumab,
chemotherapy components, and/or any of its excipients.
4. 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 before the first dose of study medication.
5. 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.
6. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or
has current pneumonitis/interstitial lung disease.
Note: Lymphangitic spread of the NSCLC is not exclusionary.
7. Active infection requiring systemic therapy.
8. Known history of HIV infection. No HIV testing is required unless mandated by local
health authority.
Has a known history of Hepatitis B (defined as 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.
10. History or current evidence of any condition, therapy, or laboratory abnormality, or other
circumstance that might confound the results of the study or interfere with the
participant's participation for the full duration of the study, such that it is not in the best
interest of the participant to participate, in the opinion of the treating investigator.
11. Known psychiatric or substance abuse disorder that would interfere with the participant’s
ability to cooperate with the requirements of the study.
Prior/Concomitant Therapy
12. Received prior therapy with an anti-TIGIT, anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg,
CTLA-4, OX-40, CD137).
13. Received prior systemic anticancer therapy for metastatic disease.
Note: Participants who received adjuvant or neoadjuvant therapy are eligible if the
adjuvant/neoadjuvant therapy was completed at least 12 months before the development
of metastatic disease.
14. If the participant had major surgery, the participant must have recovered adequately from
the procedure and/or any complications from the operation before starting study
intervention.
15. Received prior radiotherapy within 2 weeks of start of study intervention or have had a
history of radiation pneumonitis.
Note: Participants must have recovered from all radiation-related toxicities and not
require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks
of radiotherapy) to non-CNS disease.
16. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose
of study intervention.
17. Received a live or live attenuated vaccine within 30 days before the first dose of study
intervention. Administration of killed vaccines are allowed.
Pemetrexed-Specific Concomitant Therapy
18. Is unable to interrupt aspirin or other NSAIDs, other than an aspirin dose ≤1.3 g/day, for
a 5-day period (8-day period for long-acting agents, such as piroxicam).
19. Is unable or unwilling to take folic acid or vitamin B12 supplementation
Prior/Concurrent Clinical Study Experience
20. Currently participating in or has participated in a study of an investigational agent or has
used an investigational device within 4 weeks before the first dose of study intervention.
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.
Other Exclusions
21. History of allogenic tissue/solid organ transplant.
See Appendix 7 for country-specific requirements for exclusion criteria.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    700 participants

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