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New treatment option for Non-small Cell Lung Cancer
Official title 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)
ClinicalTrials.gov ID: NCT06345729
What this study is testing
What is Calderasib?
Calderasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as MK-1084.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 are two primary study hypotheses: Hypothesis 1: 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main inclusion and
You likely can't join if
- 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...
- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously...
- 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)
See the full eligibility criteria
- The main inclusion and
- 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...
- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS)...
- 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 one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery...
- 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 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 central nervous system 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
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Stamford, Connecticut, United States
- Miami Beach, Florida, United States
- Skokie, Illinois, United States
- Kansas City, Missouri, United States
- Springfield, Missouri, United States
- Billings, Montana, United States
- Morristown, New Jersey, United States
- Albany, New York, United States
- Cincinnati, Ohio, United States
- Kettering, Ohio, United States
- Lancaster, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- CABA, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- Camperdown, New South Wales, Australia
- Urraween, Queensland, Australia
+ 159 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Beverly Hills, California, United States; Stamford, Connecticut, United States; Miami Beach, Florida, United States; Skokie, Illinois, United States; Kansas City, Missouri, United States and 173 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.