A clinical study of MK-1084 and other treatments for lung cancer (MK-1084-007)

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 Dec 2025 → ongoing

Decision date (initial)

2025-12-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-514500-14-00

WHO UTN

U1111-1307-9569

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic, Therapy, Pharmacokinetic

1. To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to PFS per RECIST 1.1 by BICR in participants whose tumors are PD-L1 positive at TPS≥1%

Secondary objectives 8

1. To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to PFS per RECIST 1.1 by BICR in all participants
2. To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to OS in participants whose tumors are PD-L1 positive at TPS≥1% and in all participants
3. To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to ORR per RECIST 1.1 by BICR in all participants
4. To evaluate MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to ORR per RECIST 1.1 by BICR in participants whose tumors are PD-L1 positive at TPS≥1%
5. To evaluate MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to DOR per RECIST 1.1 by BICR
6. To evaluate the safety and tolerability of MK-1084 in combination with MK-3475A
7. To evaluate MK-1084 plus MK-3475A versus MK-3475A plus platinum-doublet chemotherapy with respect to the mean change from baseline in global health status/QoL, dyspnea, cough, and chest pain
8. To evaluate MK-1084 plus MK-3475A versus MK-3475A plus platinum-doublet chemotherapy with respect to the time to deterioration in global health status/QOL, dyspnea, cough, and chest pain

Conditions and MedDRA coding

Participants with KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC

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 2

1. Has nonsquamous non—small cell lung cancer (NSCLC) (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
2. If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion criteria 13

1. Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)
3. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
4. Has a gastrointestinal disorder affecting absorption
5. Is HIV positive and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
6. Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
7. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
9. Has active autoimmune disease that has required systemic treatment in the past 2 years
10. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
11. Has active infection requiring systemic therapy except those specified by protocol
12. Has history of stem cell/solid organ transplant
13. 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) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Secondary endpoints 16

1. PFS in All Participants
2. Overall Survival (OS) in Participants with PD-L1 TPS ≥1%
3. OS in All Participants
4. Overall Response Rate (ORR) in All Participants
5. ORR in Participants with PD-L1 TPS ≥1%
6. Duration of Response (DOR)
7. Number of Participants Who Experienced One or More Adverse Events (AEs)
8. Number of Participants Who Discontinued Study Treatment Due to an AE
9. Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
10. Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
11. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)
12. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
13. Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30
14. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
15. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
16. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

Investigational products

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

Test 5

Comparator 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

​Atsuko Ogino

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

​Atsuko Ogino

Third parties 8

Locations

11 EU/EEA countries · 67 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 143 files

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

Application history

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