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A phase IV study of Apricity C.A.R.E. program for Cancer Adverse events Rapid Evaluation to improve treatment outcomes of ethnic/racial minority non-small cell lung cancer (NSCLC) patients receiving immunotherapy

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05812274

Population:

Adult

Phase:

IV

The therapy you are receiving for your cancer has known side effects. If those side effects are caught early, they may be less serious, easier to treat, and less likely to lead to discontinuation of your cancer therapy. Apricity Health has created the Apricity CARE program, which includes a smart phone app called ApricityCare for monitoring and reporting these side effects, and licensed nurses who can respond to you virtually to evaluate your side effects and communicate to your doctors without delay. The app also has education material to teach you about these side effects. You can also have...
NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IBIII NON-SMALL CELL LUNG CANCER

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04302025

Population:

Adult

Phase:

II

The purpose of this study is to evaluate the safety and efficacy of different experimental targeted cancer therapies (not approved by the FDA for treatment of your type of cancer) in patients who have stage IA2, IB, II, IIA or selected IIIB non-small cell lung cancer tumors that are untreated and able to be removed by surgery. The treatments that will be investigated are the study-drugs alectinib, entrectinib, and vemurafenib plus cobimetinib. Based off of individual molecular abnormalities, each participant will be assigned to either the alectinib, entrectinib, or vemurafenib plus...
A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04410796

Population:

Adult

Phase:

II

This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This study will be adding chemotherapy to osimertinib, which could possibly add to the anticancer effects of the usual treatment and may help stop cancer from growing or spreading. Osimertinib binds to the EGFR protein and blocks its activity,...
A Phase III, Randomised, Open-Label Study of Savolitinib inCombination With Osimertinib Versus Platinum-Based DoubletChemotherapy in Participants With EGFR MutatedMET-Overexpressed and/or Amplified, Locally Advanced orMetastatic Non-Small Cell Lung Cancer

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05261399

Population:

Adult

Phase:

III

The purpose of this study is to learn more about an investigational drug called savolitinib in combination with osimertinib for the treatment of non-small cell lung cancer (NSCLC) compared to platinum-based doublet chemotherapy (a standard of care treatment). Participants will be randomly assigned to one of two study groups at the beginning of this study. This means participants will be assigned to a study group by chance, like flipping a coin or rolling dice. Investigational means that the drug is not approved by any health authority, except for use in research studies like this. People who...
A Phase III, Double-blind, Randomised, Placebo-Controlled,International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05120349

Population:

Adult

Phase:

III

The purpose of this study to learn more about whether the study drug osimertinib (TAGRISSOTM) is more effective than placebo in participants with epidermal growth factor receptor (EGFR) mutated stage IA2 or IA3 Non-Small Cell Lung Cancer (NSCLC) after complete surgical removal of the tumor. Stages IA2 and IA3 refer to tumor size. A placebo is an inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo. We are also...
A PHASE 1 OPEN-LABEL STUDY OF HER3-DXd (PATRITUMAB DERUXTECAN; U3-1402) IN COMBINATION WITH OSIMERTINIB IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC EGFR-MUTATED NON-SMALL CELL LUNG CANCER (NSCLC) (HER3-DXd [PATRITUMAB DERUXTECAN; U3-1402] IN

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04676477

Population:

Adult

Phase:

I

The purpose of this study is to determine the combination dose of patritumab deruxtecan and osimertinib that can be given to patients safely and to understand how well patritumab deruxtecan alone or in combination with osimertinib works to treat lung cancer. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. Osimertinib has already been approved by several regulatory authorities for the treatment of patients with advanced non-small cell lung cancer whose tumors contain specific EGFR mutations. This will be the first time patritumab deruxtecan is used in combination with...
A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04036682

Population:

Adult

Phase:

I/II

This is a research study evaluating a new investigational drug, called CLN-081. CLN-081 is a type of drug called a tyrosine kinase inhibitor. It targets a mutation in the tumor cell called EGFR exon 20 insertion with the goal to slow down or stop cancer cell growth. It is taken orally (by mouth). There are several different parts to this study, each with different study objectives, eligibility for entry and schedules of treatment. Participants at Columbia University Irving Medical Center may take part in either Module B Part 2 or Module C. If you are enrolled to Module B, part 2, the purpose...
A Phase III, Randomized, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04351555

Population:

Adult

Phase:

III

The purpose of this study is to see whether the medication osimertinib (TAGRISSOTM) alone or when used in combination with chemotherapy is more effective than chemotherapy alone for the treatment of early stage Non-Small Cell Lung Cancer prior to surgery. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. When a tumor is found to have this type of mutation, there is a class of drugs known as EGFR tyrosine kinase inhibitors (TKIs) which target the mutation to treat the patient. Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Do you have documented non-...
A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head Neck Squamous Cell

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT04892173

Population:

Adult

Phase:

III

The purpose of this research study is to evaluate the safety and effectiveness (how well the study drug works) of NBTRX3 administered via intratumoral injections (injected directly into tumor) and used together with radiotherapy or radiotherapy combined with cetuximab, and how it compares with radiotherapy alone, or radiotherapy combined with cetuximab. NBTXR3 holds nanoparticles called hafnium oxide that works to increase the energy dose deposit within tumor cells when they are activated by ionizing radiation, which destroys cancer cells by causing damage to their membranes. NBTXR3 is an...
A phase 1 study of JNJ-86974680, an A2a receptor antagonist, administered asmonotherapy and in combination with cetrelimab and radiotherapy for advanced nonsmallcell lung cancer

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06116786

Population:

Adult

Phase:

I

The purpose of this study is to find out if JNJ-86974680 taken by itself or together with Cetrelimab and radiotherapy can cause side effects which are unexpected or unwanted reactions. This is the first time that JNJ-86974680 is being used in people. Radiotherapy is also part of the study treatment and not part of your standard of care. JNJ-86974680 and Cetrelimab are experimental drugs and not approved by the Food and Drug Administration (FDA). JJNJ-86974680 is a small molecule that may block adenosine function. Adenosine is a chemical in the body that can reduce the ability of your immune...

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