RecruitingPhase 3

A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests calderasib plus pembrolizumab as the first treatment for non-small cell lung cancer that has spread nearby or to other parts of the body. It is for people whose cancer has a KRAS G12C gene change and PD-L1 protein on at least 50% of tumor cells. Researchers will check safety and whether adding calderasib helps people live longer without cancer getting worse than adding a placebo (a treatment with no active drug).

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by testing tissue or cells.
  • Have newly diagnosed stage IIIB or IIIC cancer that cannot be cured with surgery or chemotherapy and radiation, or have stage IV cancer.
  • Have cancer with a KRAS G12C gene change and PD-L1 protein on at least 50% of tumor cells.
  • Provide a tumor sample collected within 5 years or a new sample, from an area not treated with radiation.
  • Have recovered from side effects of earlier cancer treatments to below grade 1 or your usual health level.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you test positive for hepatitis B surface antigen, have taken antiviral medicine for at least 4 weeks and have no virus detected in your blood.
  • If you have had hepatitis C, have no virus detected in your blood.

Who can't join

  • Have small cell lung cancer, including a tumor with both small cell and other cancer cells.
  • Have a history of inflammatory bowel disease, or a cancer-related nerve or brain condition called neurologic paraneoplastic syndrome.
  • Have an infection needing whole-body treatment, with some exceptions; uncontrolled serious heart or blood vessel disease; or HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease.
  • Have already received whole-body cancer treatment for this advanced lung cancer, or had lung radiation above 30 Gray within the past 6 months.
  • Had radiation outside the brain or spinal cord within 2 weeks of starting study treatment, have not recovered from radiation side effects, needed steroid medicines, or had lung inflammation from radiation.
  • Have active cancer spread to the brain or spinal cord or their lining, or another cancer that is growing or needed treatment within the past 3 years.
  • Have an immune system disease needing whole-body treatment within 2 years, current lung inflammation or scarring, or past noninfectious lung inflammation or scarring that needed steroids.
  • Have received tissue or an organ from a donor, or have not fully recovered from major surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) * Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8 * Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (PD-L1) status, and biomarker research * If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline * If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART) * If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable Exclusion Criteria: * Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease * Has known history of, or active, neurologic paraneoplastic syndrome * Has an active infection requiring systemic therapy, with exceptions * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC * Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention * Has received radiotherapy to non-central nervous system (CNS) disease within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis * Has known active CNS metastases and/or carcinomatous meningitis * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has history of allogenic tissue/solid organ transplant * Has not fully recovered from any effects of major surgical procedure

Study sites (15)

CA

CT

FL

IL

MO

MT

NJ

NY

OH

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) · Cincinnati, OH 45219Study Coordinator · Study contact · 513-556-6000More trials in Cincinnati
  • Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) · Kettering, OH 45429More trials in Kettering

PA

TX

WI