At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Calderasib (drug), Placebo (other), Pembrolizumab (biological)
- How long the study runs
- Study runs about 81 months (dates as stated)
- About the drug or intervention
- Calderasib — drug: Oral tablets · Placebo — other: Oral tablets · Pembrolizumab — biological: IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 348
- Started
- 2024-05-24
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 348 participants
- • 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%
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Milton Keynes - Milton Keynes Hospital ( Site 2304)
- • Exeter - Royal Devon & Exeter Hospital-Oncology ( Site 2302)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 is one primary study hypothesis: 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).
More detail
Per Protocol Amendment 04, overall survival (OS) was moved to be a secondary outcome measure. Additionally, no new participants will be offered Second Course treatment for pembrolizumab.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ recovered to \< Grade 1 or baseline
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓Has confirmed by testing a sample diagnosis of non-small cell lung cancer (NSCLC)
- ✓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...
- ✓If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
Who cannot take part
- ✗Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is...
- ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of...
- ✗Has known history of, or active, neurologic paraneoplastic syndrome
- ✗Has an active infection requiring treatment that goes through your whole body, with exceptions
- ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
See the full criteria
Where Is This Study? (2 UK sites)
Milton Keynes Hospital ( Site 2304)
Milton Keynes MK6 5LD, United Kingdom
Royal Devon & Exeter Hospital-Oncology ( Site 2302)
Exeter EX2 5DW, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
