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Clinical Trials List

Protocol NumberMK7902-007(E7080-G000-314)
NCT Number(ClinicalTrials.gov Identfier)NCT03829332
Completed

2019-02-01 - 2024-08-14

Phase III

Recruiting6

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Non-small Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

  • 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 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 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 Recruiting

Principal Investigator Chia-I Shen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 褚乃銘 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

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

Non-small Cell Lung Cancer (NSCLC)

Objectives

 Objective: To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, for the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.  Objective: To compare overall survival (OS) for the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo.

Test Drug

KEYTRUDA®/LENVIMA®

Active Ingredient

Lenvatinib mesilate
Pembrolizumab

Dosage Form

injection
capsule
capsule

Dosage

10mg/4 mL
4mg
10mg

Endpoints

Primary Outcome Measures :
-Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 24 months ]
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per 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. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed per RECIST 1.1 will be presented.

-Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]
OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.

Inclution Criteria

1. Have a histologically or cytologically confirmed diagnosis of NSCLC.
− Note: Mixed tumors will be categorized by the predominant cell type; if small-cell
elements are present, the participant is ineligible.
2. Have Stage IV NSCLC (American Joint Committee on Cancer [AJCC], version 8).
3. Have 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 OR presence of
a Kirsten rat sarcoma [K-ras] mutation).
− 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.
4. Have measurable disease based on RECIST 1.1, as determined by the local site.
− Note: 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. Tumor tissue that demonstrates PD-L1 expression in ≥1% of tumor cells (TPS ≥1%) as
assessed by IHC 22C3 pharmDx at a central laboratory.
− Note: Assessment of PD-L1 expression must be made from provided archival
tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
not previously irradiated. (A fine-needle aspirate, frozen sample, plasticembedded sample, cell block, clot, bone, bone marrow, cytologic specimen, or
decalcified or formalin-fixed sample that was frozen at any point will not be
acceptable for analysis). Formalin-fixed, paraffin-embedded tissue blocks are
preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Demographics
6. Be ≥18 years of age, inclusive, at the time of signing the ICF.
7. Have a life expectancy of at least 3 months.
8. Have an ECOG performance status of 0 or 1 within 7 days before the first dose of study
intervention but before randomization.
Contraceptive use by men and women should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies.
Male Participants
9. Male participants are eligible to participate if they agree to the following during the
intervention period and for at least 120 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
 Must 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 penilevaginal penetration.
 Refrain from donating sperm for at least 120 days after the last dose of lenvatinib.
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:
 Is not a WOCBP.
OR
 Is a WOCBP and using 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 120 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.
 A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as
required by local regulations) within 72 hours 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 ar e
located in Appendix 2.
 The investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a woman with an early
undetected pregnancy.
Informed Consent
11. The participant (or legally acceptable representative if applicable) provides written
informed consent/assent for the study.
Additional Categories
12. Have adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive
medications within 1 week before randomization.
− Note: Participants must not have a history of uncontrolled or poorly controlled
hypertension, defined as >150/90 mm Hg for >4 weeks despite standard medical
management.
13. Have adequate organ function as defined in the following table (Table 1). Specimens
must be collected within 10 days before the start of study intervention.

Exclusion Criteria

Medical Conditions
1. Has known untreated central nervous system 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: repeat imaging should be performed during study screening),
clinically stable, and without requirement of steroid treatment for at least 14 days before
first dose of study intervention.
2. Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor
bleeding within 2 weeks before the first dose of study intervention.
3. Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor
invasion/infiltration of major blood vessels should be considered because of the potential
risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib
therapy.
4. Has a known history of an additional malignancy, except if the participant has undergone
potentially curative therapy with no evidence of that disease recurrence for at least
3 years since initiation of that therapy.
− Note: The time requirement for no evidence of disease for at least 3 years does
not apply to the NSCLC for which a participant is enrolled in the study. The time
requirement also does not apply to participants who underwent successful
definitive resection of basal cell carcinoma of the skin, superficial bladder cancer,
squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ
cancers.
5. Has an active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with the 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 and is allowed.
6. Has had an allogeneic tissue/solid organ transplant.
7. Has a known history of human immunodeficiency virus (HIV) infection; HIV testing is
not required unless mandated by the local health authority.
8. Has a history of (noninfectious) pneumonitis that required systemic steroids or current
pneumonitis/interstitial lung disease.
9. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
reactive or hepatitis B virus [HBV]-DNA detected) or known active hepatitis C virus
(HCV, defined as HCV-RNA [qualitative] 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 the
local health authority.
10. Has a history of a gastrointestinal condition or procedure that in the opinion of the
investigator may affect oral study drug absorption.
11. Has significant cardiovascular impairment within 12 months of the first dose of study
intervention, such as a history of congestive heart failure greater than New York Heart
Association Class II, unstable angina, myocardial infarction, cerebrovascular accident
(CVA)/stroke, or cardiac arrhythmia associated with hemodynamic instability.
12. Has not recovered adequately from any toxicity and/or complications from major surgery
before starting therapy.
13. Has a known history of active tuberculosis (TB).
14. Has an active infection requiring systemic therapy.
15. Has a known psychiatric or substance abuse disorder that would interfere with the
participant’s cooperation for the requirements of the study.
16. Previously had a severe hypersensitivity reaction to treatment with an mAb or has a
known sensitivity or intolerance to any component of lenvatinib or pembrolizumab.
17. WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of
study intervention. 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 intervention, another pregnancy test (urine or
serum) must be performed and must be negative for the participant to start
receiving study intervention.
18. 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 study intervention.
Prior/Concomitant Therapy
19. Has received prior systemic chemotherapy or other targeted or biological antineoplastic
therapy for their metastatic NSCLC.
− Note: Prior treatment with chemotherapy and/or radiation as part of
neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is
allowed as long as therapy was completed at least 6 months before the diagnosis
of metastatic NSCLC.
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) or has received lenvatinib as monotherapy or in combination with
anti-PD-1 agents.
21. Has received radiotherapy within 14 days before the first dose of study intervention or
received lung radiation therapy of >30 Gy within 6 months before the first dose of study
intervention.
− Note: Participants must have recovered from all radiation-related toxicities to
Grade 1 or less, not require corticosteroids, and not have had radiation
pneumonitis.
22. Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive
therapy within 7 days before the first dose of study intervention.
23. Is receiving systemic steroid therapy (doses exceeding 10 mg daily of prednisone
equivalent) within 7 days before the first dose of study intervention.
24. Has received a live vaccine within 30 days before the first dose of study intervention.
− 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.
Prior/Concurrent Clinical Study Experience
Not applicable.
Diagnostic Assessments
25. Participants with proteinuria >1+ on urine dipstick testing/urinalysis will undergo
24-hour urine collection for quantitative assessment of proteinuria. Participants with
urine protein ≥1 g/24 hours will be ineligible.
26. Prolongation of QTc interval to >480 ms and/or left ventricular ejection fraction (LVEF)
below the institutional normal range as determined by a multigated acquisition scan
(MUGA) or echocardiogram (ECHO).
Other Exclusions
27. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study or interfere with the participant's ability to
participate for the full duration of the study, or it is not in the best interest of the
participant to participate, in the opinion of the treating investigator.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    620 participants

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