Non-small Cell Lung Cancer study: Calderasib vs Durvalumab
Official title A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
ClinicalTrials.gov ID: NCT07554339
What this study is testing
What is Calderasib?
An investigational oral tablet being studied for locally advanced non‑small cell lung cancer with a 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
- The study wants to see if the combination of calderasib and durvalumab keeps cancer from growing or spreading longer than placebo with durvalumab.
- Who it's for
- Adults with locally advanced non‑small cell lung cancer that has a KRAS G12C mutation and has not been surgically removed.
- What's involved
- Participants will receive either the drug combination or a placebo, along with the immunotherapy durvalumab, and will have regular visits and tests to monitor the cancer.
- Time commitment
- The trial lasts about 2 years, with scheduled clinic visits and tests throughout the study period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with...
- Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
- Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1...
- Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
You likely can't join if
- Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
- Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received prior treatment (other than definitive CCRT) for NSCLC.
See the full eligibility criteria
- Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
- Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
- Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
- Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
- Has a body weight ≥35 kg.
- Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
- Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received prior treatment (other than definitive CCRT) for NSCLC.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
- Has an active infection requiring systemic therapy.
- Has a 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
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Lisle, Illinois, United States
- Lincoln, Nebraska, United States
- New Brunswick, New Jersey, United States
- Albany, New York, United States
- Raleigh, North Carolina, United States
- Fairfax, Virginia, United States
- Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Rosario, Santa Fe Province, Argentina
- Frenchs Forest, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Frankston, Victoria, Australia
- Fortaleza, Ceará, Brazil
- Vitória, Espírito Santo, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
+ 76 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 Atlanta, Georgia, United States; Savannah, Georgia, United States; Lisle, Illinois, United States; Lincoln, Nebraska, United States; New Brunswick, New Jersey, United States; Albany, New York, United States and 90 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.