RightFit
RecruitingPhase 3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

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 is for people with advanced nonsquamous non-small cell lung cancer, a type of lung cancer. It compares calderasib plus pembrolizumab shots under the skin with pembrolizumab shots plus chemotherapy to see which helps people live longer without cancer growing or spreading. Calderasib targets a gene change called KRAS G12C.

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.

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

Eligibility

Who can join

  • Have stage IIIB or IIIC nonsquamous non-small cell lung cancer that cannot be treated with surgery or combined chemotherapy and radiation to cure it, or have stage IV cancer that has spread.
  • If you have HIV, it must be well controlled with HIV medicines.

Who can't join

  • Have small cell lung cancer, even as part of a mixed tumor, or another cancer that is growing or has needed treatment in the past 3 years.
  • Have active bowel inflammation needing medicines that weaken the immune system, or a clear past history of bowel inflammation, such as Crohn’s disease, ulcerative colitis, or chronic diarrhea. A gut problem that affects absorption also excludes you.
  • Have serious, uncontrolled heart or blood vessel disease, including disease of blood vessels in the brain.
  • Have HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease, or an active infection needing treatment throughout the body, unless the study rules allow it.
  • Have already had cancer medicine that treats the whole body for advanced or spreading non-small cell lung cancer.
  • Have active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.
  • Have an autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years. Current lung inflammation or scarring, or past noninfectious lung inflammation or scarring that needed steroids, also excludes you.
  • Have had a stem cell or organ transplant, have not recovered enough from major surgery, or still have problems from surgery.

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

Official eligibility criteria

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 sites (15)

AL

CT

FL

GA

IN

ME

NJ

NY

OR

PA

VA