BridgeMD
Compares treatment options for Non-small Cell Lung Cancer (NSCLC)
Official title A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
ClinicalTrials.gov ID: NCT07566052
What this study is testing
What is Setidegrasib?
Setidegrasib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Also referred to as ASP3082.
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
- Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells.
- 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
- Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat...
- The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization.
- If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the...
- Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to...
- No additional treatments are allowed in the locally advanced (unresectable) or metastatic setting, with the exception of: Anti-vascular endothelial...
You likely can't join if
- Participant has known untreated or symptomatic central nervous system (CNS) metastases. Participant with previously treated brain metastases may be...
- Participant has mixed small-cell lung cancer and NSCLC histology.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2...
- Participant has known hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or anti HBV core antibody-positive)...
- Participant with human immunodeficiency virus (HIV) infection may be eligible if the participant has not had an opportunistic infection within the...
See the full eligibility criteria
Who can join
- Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status...
- The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization.
- If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the participant is enrolling via central testing, the eligibility sample must be...
- Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to platinum combinations with pemetrexed, paclitaxel, etoposide or...
- No additional treatments are allowed in the locally advanced (unresectable) or metastatic setting, with the exception of: Anti-vascular endothelial growth factor (VEGF) therapy (e.g., bevacizumab), when administered in...
- Anti-CTLA-4 antibodies (e.g., ipilimumab, tremelimumab), when administered in combination with anti-PD-1/PD-L1 (with or without platinum-based chemotherapy) as part of a standard regimen in the locally advanced...
- For the purposes of eligibility, for a participant who has received prior neoadjuvant or adjuvant therapy and has had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy...
- For the purposes of eligibility, for a participant with a history of unresectable Stage III disease who has received prior multi-modal therapy and has had recurrence on or within 6 months of completion of therapy, the...
- Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP).
- WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview) and agrees to follow the contraceptive guidance from the time of informed consent through ≥ 6 months...
- Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel...
- Must not donate ova starting at first administration of study intervention and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel...
- Participant consents to and provides a baseline tumor tissue and plasma specimen during prescreening and/or screening.
- Participant has an ECOG performance status of 0 or 1 within 7 days prior to randomization.
What rules you out
- Participant has known untreated or symptomatic central nervous system (CNS) metastases. Participant with previously treated brain metastases may be eligible if they have stable CNS disease for ≥ 2 weeks prior to...
- Participant has mixed small-cell lung cancer and NSCLC histology.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for...
- Participant has known hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or anti HBV core antibody-positive) or known hepatitis C virus (HCV) (defined as HCV RNA [qualitative]...
- Participant with human immunodeficiency virus (HIV) infection may be eligible if the participant has not had an opportunistic infection within the past 12 months. Participant must be on established antiretroviral...
- Participant has current grade ≥ 2 peripheral neuropathy.
- Participant has uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Participant with PleurX catheters in place may be considered...
- Participant has received therapeutic or palliative radiation therapy within 14 days prior to randomization (see first Exclusion Criteria for CNS metastases); participant must have recovered from all radiotherapy related...
- Participant has a known actionable mutation for which an approved targeted therapy is locally available, including, but not limited to, KRAS G12C mutation, EGFR mutation (exon 19 deletions, exon 21 L858R point mutation...
- Participant has received prior treatment with either docetaxel or a KRAS-targeting agent (including KRAS directed inhibitors, degraders, siRNA, vaccines and cellular therapies).
- Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450 (CYP)3A or CYP2D6 or strong inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) or organic...
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Edison, New Jersey, United States
- Arlington, Virginia, United States
- Sapporo, Hokkaido, Japan
- Natori-shi, Miyagi, Japan
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 - 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?
Study sites include Glendale, California, United States; Edison, New Jersey, United States; Arlington, Virginia, United States; Sapporo, Hokkaido, Japan; Natori-shi, Miyagi, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.