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New treatment option for Lung Non-Small Cell Carcinoma
Official title Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial
ClinicalTrials.gov ID: NCT07288034
What this study is testing
What is Adagrasib?
Adagrasib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lung non-small cell carcinoma.
Also referred to as KRAS G12C Inhibitor MRTX849, Krazati.
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 phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
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
- Documented informed consent of the participant and/or legally authorized representative. (Adult patients lacking capacity to consent may participate...
- Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR...
- Agreement to blood collection for ctDNA research
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
You likely can't join if
- Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
- Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another...
- Radiation therapy within 7 days prior to day 1 of protocol therapy
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of...
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use...
- Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS...
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative. (Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure compliance.)
- Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR B) archival or new biopsy tissue available (to be sent to Tempus)...
- Agreement to blood collection for ctDNA research
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Histologically confirmed stage IIIB or IV NSCLC
- Absence of sensitizing EGFR mutation or ALK/ROS1 alteration
- Scheduled to begin treatment with a Food and Drug Administration (FDA) approved PD1/PDL1 antibody with or without chemotherapy. Participants who have already started treatment with anti-PD1/PDL1 in this setting may...
- Measurable disease by RECIST version (v) 1.1
- Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
- NOTE: Growth factor is not permitted within 14 days of ANC assessment
- Platelets ≥ 100,000/mm\^3
- NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
- Hemoglobin ≥ 9g/dL
- NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
- Alanine aminotransferase (ALT) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
- Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
- If seropositive for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- PART II: Documented informed consent (for Part II) of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- PART II: ECOG ≤ 2
- PART II: Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
- PART II: ANC ≥ 1,500/mm\^3
- NOTE: Growth factor is not permitted within 14 days of ANC assessment
- PART II: Platelets ≥ 100,000/mm\^3
- NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
- PART II: Hemoglobin ≥ 9g/dL
- NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
- PART II: Total bilirubin ≤ 1.5 x ULN
- PART II: AST ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
- PART II: ALT ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
- PART II: Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
What rules you out
- Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
- Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study...
- Radiation therapy within 7 days prior to day 1 of protocol therapy
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart...
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs
- Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid...
- Prior history of interstitial lung disease (ILD) or non-infectious pneumonitis requiring high-dose glucocorticoids
- Active infection requiring antibiotics
- Other active malignancy. Patients with concurrent malignancy other than non-melanoma skin cancer are not eligible for this trial due to potential confounding of the ctDNA results
- Females only: Pregnant or breastfeeding
- PART II: Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
- PART II: Radiation therapy within 7 days prior to day 1 of protocol therapy
- PART II ARM A ONLY: Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first...
- PART II ARM A ONLY: Patients with prior history of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) treatment
- PART II ARM B ONLY: Patients with prior history of KRAS G12C inhibitors
- PART II: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart...
- PART II ARM A ONLY: Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive...
- PART II ARM B ONLY: Grade ≥ 2 proteinuria as demonstrated by ≥ 2+ protein and ≥ 1.0 g of protein with 24-hour urine collection (patients found to have ≥ 2+ protein on dipstick urinalysis must have 24-hour urine...
- PART II: Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement...
- PART II: Clinically significant uncontrolled illness
- PART II: Active infection requiring antibiotics
- PART II: Other active malignancy
- PART II FEMALES ONLY: Pregnant or breastfeeding
- PART II: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Corona, California, United States
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Newport Beach, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
- Newnan, Georgia, United States
- Zion, Illinois, United States
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Goodyear, Arizona, United States; Corona, California, United States; Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; Lancaster, California, United States and 7 more location(s). 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.