Clinical trial for Non-small Cell Lung Cancer
Official title A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
ClinicalTrials.gov ID: NCT07190248
What this study is testing
What is Calderasib?
Calderasib is an investigational oral tablet being studied as a potential treatment for non-small cell lung cancer. It is designed to target the KRAS G12C mutation.
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 study is testing whether adding calderasib to pembrolizumab works better than pembrolizumab with chemotherapy. It looks at how long the cancer stays under control.
- Who it's for
- You may be able to join if you have non-small cell lung cancer with a specific gene change.
- What's involved
- You would get calderasib and pembrolizumab shots. You would also get regular check-ups and tests.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- Phase 3: a large, late-stage study
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
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Beverly Hills, California, United States
- Farmington, Connecticut, United States
- Stamford, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Savannah, Georgia, United States
- Lafayette, Indiana, United States
- Westbrook, Maine, United States
- Minneapolis, Minnesota, United States
- Hackensack, New Jersey, United States
- Albany, New York, United States
- Rochester, New York, United States
- Bend, Oregon, United States
- Lancaster, Pennsylvania, United States
- Fredericksburg, Virginia, United States
- Midlothian, Virginia, United States
- Roanoke, Virginia, United States
- Morgantown, West Virginia, United States
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
+ 168 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 Birmingham, Alabama, United States; Beverly Hills, California, United States; Farmington, Connecticut, United States; Stamford, Connecticut, United States; Fort Lauderdale, Florida, United States; Savannah, Georgia, United States and 182 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.