A clinical trial of MK-1084, pembrolizumab, and chemotherapy in people with nonsmall cell lung cancer (MK-1084-013)

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

12 May 2026 → ongoing

Decision date (initial)

2026-04-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-517337-41-00

WHO UTN

U1111-1312-0627

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Pharmacodynamic, Pharmacokinetic, Safety

1. To compare adjuvant MK-1084 plus MK-3475A to placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by investigator

Secondary objectives 5

1. To compare adjuvant MK-1084 plus MK-3475A to placebo plus MK-3475A with respect to overall survival (OS).
2. To evaluate adjuvant MK-1084 plus MK-3475A and placebo plus MK-3475A with respect to distant metastasis-free survival (DMFS) as assessed by the investigator.
3. To evaluate MK-1084 plus MK-3475A and placebo plus MK-3475A with respect to lung cancer specific survival (LCSS).
4. To evaluate adjuvant MK-1084 plus MK-3475A and placebo plus MK-3475A with respect to mean change from baseline in global health status/QoL, physical functioning, role functioning, and lung cancer symptoms using the EORTC QLQ-C30 and EORTC QLQ-LC24.
5. To evaluate the safety and tolerability of MK-1084 plus MK-3475A.

Conditions and MedDRA coding

Completely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLC

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria: • Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC • Has completely resected, pathological Stage IIA–IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy
2. Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
3. No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
4. Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
6. Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
7. Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
8. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion criteria 10

1. Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
2. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
5. Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
6. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
7. Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
8. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
9. Has active infection requiring systemic therapy
10. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-Free Survival (DFS)

Secondary endpoints 11

1. Overall Survival (OS)
2. Distant Metastasis-Free Survival (DMFS)
3. Lung Cancer Specific Survival (LCSS)
4. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
5. Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
6. Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
7. Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score
8. Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score
9. Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score
10. Number of Participants Who Experience an Adverse Event (AE)
11. Number of Participants Who Discontinue Study Treatment Due to an AE

Investigational products

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

Test 3

Placebo 1

Auxiliary 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

Jeffrey Thompson

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jeffrey Thompson

Third parties 8

Locations

6 EU/EEA countries · 42 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

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