Clinical Trials List
Protocol NumberMK-3475-01G
Active
2025-10-01 - 2034-12-31
Phase II
Recruiting3
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
KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
-
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林慶雄 Division of Thoracic Medicine
- 陳正雄 Division of Thoracic Medicine
- 蔡偉宏 Division of Thoracic Medicine
- 林明泰 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 葉金水 Division of Thoracic Medicine
- 林俊維 Division of Thoracic Medicine
- 張時榮 Division of Thoracic Medicine
- 詹博強 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 黃國揚 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
- Kai-Ling Lee Division of Thoracic Medicine
- 高冠鈞 Division of Hematology & Oncology
- Mei-Chuan Chen Division of Thoracic Medicine
- Shang-Fu Hsu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-small Cell Lung Cancer (NSCLC)
Objectives
To evaluate ORR per RECIST 1.1 as assessed by BICR
Test Drug
Injection
Active Ingredient
patritumab deruxtecan
Pembrolizumab
Pembrolizumab
Dosage Form
270
270
270
Dosage
100 mg/Vial
100 mg/4 mL
100 mg/4 mL
Endpoints
OR: confirmed CR or PR
Inclution Criteria
An individual is eligible for inclusion in the study if the individual meets all of the following
criteria:
Type of Participant and Disease Characteristics
1. Histologically or cytologically confirmed diagnosis of Stage IV (M1a, M1b, or M1c per
AJCC Staging Manual, Version 8) squamous or nonsquamous NSCLC.
Note: Mixed tumors will be characterized by the predominant cell type (squamous or
nonsquamous); however, small cell elements are not permitted.
2. Participants with nonsquamous histology should have confirmation per local test report
that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
(documentation of absence of tumor-activating EGFR mutations AND absence of ALK
and ROS1 gene rearrangements OR presence of a KRAS mutation).
3. Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR.
Lesions situated in a previously irradiated area are considered measurable if progression
has been shown in such lesions.
4. Life expectancy of at least 3 months.
5. An ECOG performance status of either 0 or 1 as assessed within 7 days before
randomization.
Demographics
6. Is an individual of any sex/gender who is at least 18 years of age at the time of providing
informed consent.
Assigned Male Sex at Birth
7. If capable of producing sperm, the participant 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:
- Chemotherapy: 90 days
- Pembrolizumab: No contraception required
- HER3-DXd: 120 days
• Refrains from donating sperm
PLUS either:
• Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent
on a long-term and persistent basis) and agrees to remain abstinent
OR
• Uses a penile/external condom when having penile-vaginal intercourse with a
nonparticipant of childbearing potential who is not currently pregnant PLUS partner use
of an additional contraceptive method (refer to Appendix 5), as a condom may break or
leak
• Contraceptive use 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 are more stringent than the
requirements above, the local label requirements are to be followed.
Note: If the participant is 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), no contraception is required.
Assigned Female Sex at Birth
8. A participant assigned female sex at birth is eligible to participate if not breastfeeding
during the study intervention period and for at least 120 days after the last dose of study
intervention.
9. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive
pregnancy test (urine or serum), as required by local regulations, has been obtained
within 24 hours (for a urine test) or 72 hours (for a serum test) 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. Additional requirements for pregnancy testing
during and after study intervention are in Section 8.3.7.
10. A POCBP is eligible to participate if they use a contraceptive method that is highly
effective (with a failure rate of <1% per year), with low user dependency, or if they
adhere to penile-vaginal intercourse abstinence 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. In addition, the participant agrees not to donate
eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of
reproduction. The length of time required to continue contraception for each study
intervention is:
◦ Pembrolizumab: 120 days
◦ Chemotherapy: 180 days
◦ HER3-DXd: 210 days
Note: The investigator should evaluate the potential for contraceptive method failure (ie,
noncompliance, recent initiation) in relationship to the first dose of study intervention.
Contraceptive use by POCBPs should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies. If the local
contraception requirements for any of the study interventions are more stringent than the
requirements above, the local label requirements are to be followed. Medical history,
menstrual history, and recent sexual activity should be reviewed by the investigator to
decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
criteria:
Type of Participant and Disease Characteristics
1. Histologically or cytologically confirmed diagnosis of Stage IV (M1a, M1b, or M1c per
AJCC Staging Manual, Version 8) squamous or nonsquamous NSCLC.
Note: Mixed tumors will be characterized by the predominant cell type (squamous or
nonsquamous); however, small cell elements are not permitted.
2. Participants with nonsquamous histology should have confirmation per local test report
that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
(documentation of absence of tumor-activating EGFR mutations AND absence of ALK
and ROS1 gene rearrangements OR presence of a KRAS mutation).
3. Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR.
Lesions situated in a previously irradiated area are considered measurable if progression
has been shown in such lesions.
4. Life expectancy of at least 3 months.
5. An ECOG performance status of either 0 or 1 as assessed within 7 days before
randomization.
Demographics
6. Is an individual of any sex/gender who is at least 18 years of age at the time of providing
informed consent.
Assigned Male Sex at Birth
7. If capable of producing sperm, the participant 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:
- Chemotherapy: 90 days
- Pembrolizumab: No contraception required
- HER3-DXd: 120 days
• Refrains from donating sperm
PLUS either:
• Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent
on a long-term and persistent basis) and agrees to remain abstinent
OR
• Uses a penile/external condom when having penile-vaginal intercourse with a
nonparticipant of childbearing potential who is not currently pregnant PLUS partner use
of an additional contraceptive method (refer to Appendix 5), as a condom may break or
leak
• Contraceptive use 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 are more stringent than the
requirements above, the local label requirements are to be followed.
Note: If the participant is 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), no contraception is required.
Assigned Female Sex at Birth
8. A participant assigned female sex at birth is eligible to participate if not breastfeeding
during the study intervention period and for at least 120 days after the last dose of study
intervention.
9. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive
pregnancy test (urine or serum), as required by local regulations, has been obtained
within 24 hours (for a urine test) or 72 hours (for a serum test) 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. Additional requirements for pregnancy testing
during and after study intervention are in Section 8.3.7.
10. A POCBP is eligible to participate if they use a contraceptive method that is highly
effective (with a failure rate of <1% per year), with low user dependency, or if they
adhere to penile-vaginal intercourse abstinence 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. In addition, the participant agrees not to donate
eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of
reproduction. The length of time required to continue contraception for each study
intervention is:
◦ Pembrolizumab: 120 days
◦ Chemotherapy: 180 days
◦ HER3-DXd: 210 days
Note: The investigator should evaluate the potential for contraceptive method failure (ie,
noncompliance, recent initiation) in relationship to the first dose of study intervention.
Contraceptive use by POCBPs should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies. If the local
contraception requirements for any of the study interventions are more stringent than the
requirements above, the local label requirements are to be followed. Medical history,
menstrual history, and recent sexual activity should be reviewed by the investigator to
decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
Exclusion Criteria
An individual must be excluded from the study if the individual meets any of the following
criteria:
Medical Conditions
1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
2. Participants with squamous histology are excluded if there is a known tumor-activating
EGFR mutation or ALK or ROS1 gene rearrangement. Molecular testing is not required.
3. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric
Castleman’s Disease.
4. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli
within 3 months before randomization, severe asthma, severe chronic obstructive
pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune,
connective tissue, or inflammatory disorders with pulmonary involvement (ie,
rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc), or prior complete
pneumonectomy.
5. Evidence of any leptomeningeal disease.
6. Known history of, or active, neurologic paraneoplastic syndrome.
7. Has clinically significant corneal disease.
8. Uncontrolled or significant cardiovascular disorder prior to randomization, including:
a. QTcF prolongation interval >450 ms (average of triplicate determinations at
screening)
b. LVEF ≤45%
c. Resting systolic blood pressure >180 mm Hg or diastolic blood pressure
>110 mm Hg)
d. Myocardial infarction within 6 months
e. NYHA Classes 3 or 4 congestive heart failure
f. Uncontrolled angina pectoris within 6 months
g. Cardiac arrhythmia requiring ongoing antiarrhythmic treatment
h. Diagnosed or suspected long QT syndrome, or known family history of long QT
syndrome
i. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia,
ventricular fibrillation, or Torsade de Pointes
j. Bradycardia of less than 50 bpm (as determined by central reading) unless the
participant has a pacemaker
k. History of second or third degree heart block. Candidates with a history of heart block
may be eligible if they currently have pacemakers, and have no history of fainting or
clinically relevant arrhythmia with pacemakers
l. Coronary/peripheral artery bypass graft within 6 months
m. Complete left bundle branch block
9. Active inflammatory bowel disease requiring immunosuppressive medication or previous
clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or
chronic diarrhea).
criteria:
Medical Conditions
1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
2. Participants with squamous histology are excluded if there is a known tumor-activating
EGFR mutation or ALK or ROS1 gene rearrangement. Molecular testing is not required.
3. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric
Castleman’s Disease.
4. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli
within 3 months before randomization, severe asthma, severe chronic obstructive
pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune,
connective tissue, or inflammatory disorders with pulmonary involvement (ie,
rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc), or prior complete
pneumonectomy.
5. Evidence of any leptomeningeal disease.
6. Known history of, or active, neurologic paraneoplastic syndrome.
7. Has clinically significant corneal disease.
8. Uncontrolled or significant cardiovascular disorder prior to randomization, including:
a. QTcF prolongation interval >450 ms (average of triplicate determinations at
screening)
b. LVEF ≤45%
c. Resting systolic blood pressure >180 mm Hg or diastolic blood pressure
>110 mm Hg)
d. Myocardial infarction within 6 months
e. NYHA Classes 3 or 4 congestive heart failure
f. Uncontrolled angina pectoris within 6 months
g. Cardiac arrhythmia requiring ongoing antiarrhythmic treatment
h. Diagnosed or suspected long QT syndrome, or known family history of long QT
syndrome
i. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia,
ventricular fibrillation, or Torsade de Pointes
j. Bradycardia of less than 50 bpm (as determined by central reading) unless the
participant has a pacemaker
k. History of second or third degree heart block. Candidates with a history of heart block
may be eligible if they currently have pacemakers, and have no history of fainting or
clinically relevant arrhythmia with pacemakers
l. Coronary/peripheral artery bypass graft within 6 months
m. Complete left bundle branch block
9. Active inflammatory bowel disease requiring immunosuppressive medication or previous
clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or
chronic diarrhea).
The Estimated Number of Participants
-
Taiwan
9 participants
-
Global
90 participants
