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New treatment option for Non-Small Cell Lung Cancer
Official title A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07619339
What this study is testing
What is Tepotinib?
Tepotinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
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 researchers are doing this study to find out whether the combination of tepotinib and ivonescimab is a safe and effective treatment for people with non-small cell lung cancer (NSCLC) that is positive for METex14 skipping. The researchers will test up to two different doses of tepotinib in combination with ivonescimab to find the best dose of tepotinib that causes few or mild side effects in participants.
- Phase 1: an early, usually small safety 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
- Criteria:
- Documentation of Disease
- Patients must have pathologically confirmed non-small cell lung cancer. This includes, but is not limited, to histologies such as adenocarcinoma...
- Patients must have documentation of MET exon 14 skipping present in their cancer using an FDA-approved assay done within a laboratory with CLIA...
- Definition of Disease
See the full eligibility criteria
Who can join
- Criteria:
- Documentation of Disease
- Patients must have pathologically confirmed non-small cell lung cancer. This includes, but is not limited, to histologies such as adenocarcinoma, squamous cell carcinoma, sarcomatoid carcinoma, and poorly differentiated...
- Patients must have documentation of MET exon 14 skipping present in their cancer using an FDA-approved assay done within a laboratory with CLIA, ISO/IEC, CAP, or similar certification.
- Definition of Disease
- Patients must have advanced or recurrent disease.
- Advanced disease is defined as stage IV disease or stage IIIB/C disease not amenable to local therapy such as radiation or surgery.
- Patients must have measurable disease as defined by RECIST 1.1 criteria.
- Must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK...
- Must not have leptomeningeal disease or brain metastases unless: 1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation...
- Small/asymptomatic brain metastasis for which stereotactic radiation is indicated must be treated.
- Prior Treatment
- No prior angiogenesis inhibitor therapy (i.e. bevacizumab or ramucirumab)
- Patients can have received prior MET inhibitor therapy
- Patients can have received prior ICI therapy.
- If applicable, patients must have progressed on their most recent line of therapy.
- Must have not had prior systemic therapy within 21 days of the start of protocol therapy
- Must not have received radiation therapy within 7 days of starting protocol therapy
- Age ≥ 18
- ECOG Performance Status of ≤ 2
- Not Pregnant and Not Nursing
- Female patients of childbearing age must have negative serum pregnancy test results before randomization.
- Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of...
- Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 90 after the last dose of ivonescimab
- Required Organ Function
- Adequate hematologic function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9 g/d
- Adequate renal function defined as follows:
- Creatinine clearance (CrCL) of ≥50 mL/min by the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥ 50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation...
- Urine protein \< 2+ or 24-hour urine protein \< 1.0g
- Adequate hepatic function defined as follows:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
- AST and ALT ≤2.5x institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 x ULN.
- Coagulation: PT or INR ≤ 1.5 ULN, and PTT or aPTT ≤ 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or prophylactic anticoagulation)
- Comorbid Conditions No history of interstitial lung disease requiring steroid treatment
- Prior history of Grade ≥3 irAE
- Must not have evidence of major blood vessel invasion or tumor invading into organs or risk of esophagotracheal or esophagopleural fistula Must not have active autoimmune or lung disease requiring systemic therapy...
- Poorly controlled hypertension with repeated systolic blood pressure ≤ 150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy
- Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring...
- Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Must not have a history of unstable angina, MI, CHF (NYHA grade ≥ 2) requiring hospitalization in the preceding 6 months
- Must not have a history of gastric or esophageal varices, severe ulcers, or wounds that do not heal, or fistulas, or abscesses, or acute GI bleeding within 6 months of therapy
- Must not have a history of arterial thromboembolic event, venous thromboembolic event grade ≥ 3, CVA/TIA, HTN crisis or HTN encephalopathy within 6 months of therapy
- Must not have a history of bleeding tendencies or coagulopathy or clinically significant bleeding symptoms or risk within 4 weeks of therapy
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots)
- Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
- Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- For patients with known HIV, HBV, and/or HCV infection:
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable side effects for one month prior...
- All patients with active hepatitis C (hepatitis C virus [HCV] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.
- Allergies o No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 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 Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 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.