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

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

2024-518839-11-00

WHO UTN

U1111-1314-2392

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

1. To evaluate the OR per RECIST 1.1 as assessed by BICR
2. To evaluate the safety and tolerability of investigational treatments when used as monotherapy

Secondary objectives 3

1. To evaluate the DOR per RECIST 1.1 as assessed by BICR
2. To evaluate PFS per RECIST 1.1 as assessed by BICR
3. To evaluate OS

Conditions and MedDRA coding

Stage IV Squamous Non-Small Cell Lung Cancer

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
2. Has documented disease progression per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/ programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
3. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
4. Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
5. Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion criteria 17

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Has uncontrolled or significant cardiovascular disorder
3. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, 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 pneumonectomy
4. Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
5. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
6. Has clinically significant corneal disease
7. Known additional malignancy that is progressing or has required active treatment within the past 3 years
8. Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
9. Evidence of any leptomeningeal disease
10. History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
11. Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
12. Active infection requiring systemic therapy
13. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
14. Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
15. Known history of, or active, neurologic paraneoplastic syndrome
16. History of allogeneic tissue/solid organ transplant
17. Has 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 Rate (ORR)
2. Number of participants who experience one or more adverse events (AEs)
3. Number of participants who discontinue study intervention 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 2

Comparator 1

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 · 19 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 54 files

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

Application history

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