A clinical study of MK-1084 with other treatments for non-small cell lung cancer (MK-3475-01F)

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

15 Apr 2026 → ongoing

Decision date (initial)

2026-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Daiichi Sankyo · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-512248-47-00

WHO UTN

U1111-1304-4707

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Pharmacokinetic, Therapy, Dose response, Safety

1. To evaluate the safety and tolerability of investigational agent combinations
2. To evaluate ORR per RECIST 1.1 as assessed by BICR

Secondary objectives 3

1. To evaluate DOR per RECIST 1.1 as assessed by BICR
2. To evaluate PFS per RECIST 1.1 as assessed by BICR (Phase 2 only)
3. To characterize the PK of investigational agent combinations

Conditions and MedDRA coding

Non-small Cell Lung Cancer (NSCLC)

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003586-PIP01-24, EMEA-003461-PIP01-23, EMEA-002977-PIP01-21

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
2. Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
3. Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
4. Provides archival tumor tissue sample of a tumor lesion not previously irradiated
5. Has provided tissue prior to treatment allocation/randomization from a newly obtained biopsy of a tumor lesion not previously irradiated
6. Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol

Exclusion criteria 15

1. Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
4. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
5. Has evidence of any leptomeningeal disease
6. Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
7. Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
8. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
9. Has received previous treatment with an agent targeting KRAS
10. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
12. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
13. Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
14. Has an active infection requiring systemic therapy
15. Have not adequately recovered from major surgery or have ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
2. Number of Participants Who Experience an Adverse Event (AE)
3. Number of Participants Who Discontinue Study Treatment Due to an AE
4. Objective Response Rate (ORR)

Secondary endpoints 5

1. Duration of Response (DOR)
2. Progression-Free Survival (PFS)
3. Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau)
4. Maximum Plasma Concentration (Cmax)
5. Minimum Observed Concentration (Ctrough)

Investigational products

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

Test 7

Auxiliary 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

Atsuko Ogino

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Atsuko Ogino

Third parties 9

Locations

6 EU/EEA countries · 18 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 60 files

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

Application history

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