A clinical study of treatments for non-small cell lung cancer (MK-3475-01H)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Aug 2025 → ongoing

Decision date (initial)

2025-08-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC · Daiichi Sankyo

External identifiers

EU CT number

2024-518761-10-00

WHO UTN

U1111-1314-1785

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenomic, Pharmacokinetic, Safety, Pharmacodynamic, Pharmacogenetic

1. To evaluate the objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
2. To evaluate the safety and tolerability of investigational treatments when used as monotherapy

Secondary objectives 3

1. To evaluate the duration of response (DOR) per RECIST 1.1 as assessed by BICR
2. To evaluate progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
3. To evaluate overall survival (OS)

Conditions and MedDRA coding

Non-small Cell Lung Cancer

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Histologically or cytologically confirmed diagnosis of Stage IV non-squamous non-small cell lung cancer (NSCLC)
2. Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
3. Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), or c ros oncogene 1 negative (ROS1-) directed therapy is not indicated as primary therapy
4. Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
5. Life expectancy of at least 3 months
6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
7. Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
8. Has adequate organ function
9. If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
10. Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
11. Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
12. Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
13. Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
14. Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
15. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion criteria 24

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Received radiation therapy to the lung
3. Has uncontrolled or significant cardiovascular disorder prior to randomization
4. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
5. Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
6. Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
7. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
8. Has clinically significant corneal disease
9. Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
10. Has inadequate washout period prior to randomization
11. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
12. Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
13. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
14. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
15. Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
16. Has evidence of any leptomeningeal disease
17. Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
18. Has active autoimmune disease that has required systemic treatment in the past 2 years
19. Has active infection requiring systemic therapy
20. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
21. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
22. Has known history of, or active, neurologic paraneoplastic syndrome
23. Has history of allogeneic tissue/solid organ transplant
24. Have not adequately recovered from major surgery or have ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Objective Response (OR)
2. Percentage of participants with at least one adverse event (AE)
3. Percentage of participants who discontinued medication due to an AE

Secondary endpoints 3

1. Duration Of Response (DOR)
2. Progression-Free Survival (PFS)
3. Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Mark Shamoun

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Mark Shamoun

Third parties 5

Locations

6 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications