A clinical trial of MK-1084 and durvalumab in people with non-small cell lung cancer (MK-1084-015)

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

16 Jun 2026 → ongoing

Decision date (initial)

2026-06-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-522038-29-00

WHO UTN

U1111-1321-6971

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To compare MK-1084 plus durvalumab to placebo plus durvalumab with respect to PFS assessed according to RECIST 1.1 by BICR.

Secondary objectives 5

1. To compare MK-1084 plus durvalumab to placebo plus durvalumab with respect to OS.
2. To evaluate MK-1084 plus durvalumab and placebo plus durvalumab with respect to safety and tolerability.
3. To evaluate MK-1084 plus durvalumab compared to placebo plus durvalumab with respect to ORR and DOR per RECIST 1.1 as assessed by BICR.
4. To evaluate MK-1084 plus durvalumab compared to placebo plus durvalumab with respect to DMFS as assessed by investigator.
5. To evaluate MK-1084 plus durvalumab compared to placebo plus durvalumab with respect to the mean change from baseline in global health status/QoL, physical and role functioning.

Conditions and MedDRA coding

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation​

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
2. Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
3. Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
4. Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
5. If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
6. If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
7. If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
8. Has a body weight ≥35 kg.

Exclusion criteria 12

1. Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
2. Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
5. Is HIV-infected with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
6. Has received prior treatment (other than definitive CCRT) for NSCLC.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
8. Has an active autoimmune disease that has required systemic treatment in the past 2 years.
9. Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
10. Has an active infection requiring systemic therapy.
11. Has a history of stem cell/solid organ transplant.
12. Has not adequately recovered from major surgery or has ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-Free Survival (PFS)

Secondary endpoints 9

1. Overall Survival (OS)
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)
5. Duration of Response (DOR)
6. Distant Metastasis-Free Survival (DMFS)
7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score
8. Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score
9. Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score

Investigational products

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

Test 3

Placebo 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

Andrew Song

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Andrew Song

Third parties 6

Locations

7 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