Non-small Cell Lung Cancer study: Calderasib vs Pembrolizumab
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 oral tablet being studied as a potential first-line treatment for non-small cell lung cancer with a specific KRAS G12C mutation. is designed to block the activity of a specific protein called KRAS G12C that helps cancer cells grow.
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
- The study wants to see if the drug combo keeps cancer from growing longer than placebo plus pembrolizumab, measured by how long patients stay progression‑free.
- Who it's for
- It is looking for adults with advanced or metastatic non‑small cell lung cancer that has a KRAS G12C mutation and a PD‑L1 tumor proportion score of 50% or higher.
- What's involved
- Participants will receive the study drugs and have regular visits for safety checks, blood tests, and scans to monitor the cancer.
- Time commitment
- The trial lasts until the cancer progresses or the study ends, with visits every few weeks for treatment and monitoring.
- 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
- 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 sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor...
- 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...
See the full eligibility criteria
- The main inclusion and
- 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 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...
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Stamford, Connecticut, United States
- Skokie, Illinois, United States
- Kansas City, Missouri, United States
- Springfield, Missouri, United States
- Billings, Montana, United States
- Albany, New York, United States
- Cincinnati, Ohio, United States
- Lancaster, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- Berazategui, Buenos Aires, Argentina
- CABA, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Viedma, Río Negro Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Camperdown, New South Wales, Australia
- Urraween, Queensland, Australia
- Frankston, Victoria, Australia
+ 143 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, but 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?
This study is enrolling now at Bakersfield, California, United States; Beverly Hills, California, United States; Stamford, Connecticut, United States; Skokie, Illinois, United States; Kansas City, Missouri, United States; Springfield, Missouri, United States and 157 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.