Recruiting
Phase 3

MK-1084 & SC Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07190248

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calderasib

Pembrolizumab (+) Berahyaluronidase alfa

Pemetrexed

Cisplatin

Carboplatin

Study Details

Brief summary:

Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.

The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT07190248

Start date

Oct 8, 2025

Status verified date

Aug, 2026

Completion date

Aug 6, 2032

Anticipated

Primary completion date

Dec 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
  • If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • 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)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has a gastrointestinal disorder affecting absorption
  • Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy except those specified by protocol
  • Has history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Study Design

Enrollment

675 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Calderasib + Pembrolizumab (+) Berahyaluronidase alfa

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met.

active comparator: Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).

Interventions

Calderasib

Administered as an oral tablet

Pembrolizumab (+) Berahyaluronidase alfa

Administered as a SC injection

Pemetrexed

Administered as an IV Infusion

Cisplatin

Administered as an IV Infusion

Carboplatin

Administered as an IV Infusion

Primary outcome measure

  • Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 48 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Central Alabama Research ( Site 0108)

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Study Coordinator

205-949-1907

University of Connecticut Health Center ( Site 0130)

Recruiting

Farmington, Connecticut, United States, 06030-8010

Contacts

Study Coordinator

860-679-7816

Stamford Hospital ( Site 0126)

Recruiting

Stamford, Connecticut, United States, 06902

Contacts

Study Coordinator

203-276-2695

Indiana University Health Arnett Cancer Center ( Site 0116)

Recruiting

Lafayette, Indiana, United States, 47904

Contacts

Study Coordinator

765-838-6885

New England Cancer Specialists ( Site 0139)

Recruiting

Westbrook, Maine, United States, 04092

Contacts

Study Coordinator

207-303-3300

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

New York Oncology Hematology, P.C. ( Site 0119)

Recruiting

Albany, New York, United States, 12206

Contacts

Study Coordinator

518-489-3612

Wilmot Cancer Institute ( Site 0141)

Recruiting

Rochester, New York, United States, 14642

Contacts

Study Coordinator

585-275-5830

St. Charles Health System, Inc ( Site 0146)

Recruiting

Bend, Oregon, United States, 97701

Contacts

Study Coordinator

541-706-5800

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

Study Coordinator

717-544-9400

Blue Ridge Cancer Care ( Site 0144)

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

540-982-0237

Cross Cancer Institute ( Site 0203)

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Study Coordinator

7804328248

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.