Is NCT07619339 recruiting in Uniondale, NY?

Yes, NCT07619339 is currently recruiting participants at its Uniondale, NY location. This non-small cell lung cancer clinical trial is actively enrolling qualified participants.

How do I join the non-small cell lung cancer clinical trial in Uniondale?

To join this clinical trial in Uniondale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Uniondale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-Small Cell Lung Cancer Clinical Trial in Uniondale, NY

About This Non-Small Cell Lung Cancer Study in Uniondale

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion 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 carcinoma.

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 rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation.

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 and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND 2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to start of study therapy.

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

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 ivonescimab or until 1 week after last dose of tepotinib (whichever is longer).

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 (adjustment by BSA is not required for eGFR)

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 (prednisone ≤ 10mg allowed) within 2 years of treatment

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 systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)

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 as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

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 tolerability for one month prior to randomization.

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Uniondale?

Yes, this clinical trial (NCT07619339) has an active research site in Uniondale, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-Small Cell Lung Cancer Treatment Options in Uniondale, NY

If you're searching for non-small cell lung cancer treatment options in Uniondale, NY, this clinical trial (NCT07619339) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Uniondale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-small cell lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-small cell lung cancer clinical trials near you to find additional studies recruiting in your area.

Non-Small Cell Lung Cancer Clinical Trial in Uniondale, NY

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