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A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma orNon-Small Cell Lung Cancer

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05256290

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug, BDTX-1535, which is not yet approved by the United States Food and Drug Administration (FDA), in treating patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR), which may or may not help your condition during this study. However, it may help other patients in the future. Are you Eligible? (Inclusion Criteria) Adults 18 years of age or older or as permitted by applicable local regulations at the time of providing informed consent. 2. Life...
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 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 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 1B/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd), A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE-STAGE

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT06362252

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about an investigational drug, which is not approved by the United States Food and Drug Administration, called ifinatamab deruxtecan (I-DXd). It is being studied to see if it is safe and if your disease, extensive- stage small cell lung cancer (ES-SCLC), or other medical condition improves while taking it alongside other drugs, Atezolizumab, Carboplatin, and Etoposide. I-DXd is a type of drug called an antibody-drug conjugate, which is made up of 2 parts: an antibody and an anticancer drug. The antibody part binds to a protein commonly found on tumor...
A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06162221

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6291 or RMC-6236 in combination with pembrolizumab in non-small cell lung cancer (NSCLC). Both study drugs, RMC-6236 and RMC-6291, has not been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but not in combination with RMC- 6291 or RMC-6236. You will be assigned to receive RMC-6291 in combination with pembrolizumab if you have an advanced cancer which has a mutation in a gene known as KRAS^G12C. You will be assigned to receive RMC-6236 in combination with pembrolizumab if you...
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...
A Phase IIIb, Randomized, Multicenter, Open-label Study toassess the Efficacy of Durvalumab plus Tremelimumab versusPembrolizumab in Combination with Platinum-BasedChemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06008093

Population:

Adult

Phase:

III

The purpose this study to learn more about if a medication called durvalumab will work and be safe for the treatment of non small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) with certain genetic changes when given in combination with tremelimumab and standard chemotherapy. Additionally, this study is being done to better understand metastatic NSCLC and associated health problems. Durvalumab and tremelimumab are types of anti-cancer drugs called immunotherapy that target cancer cells by blocking the signal that prevents the immune system from seeing the...
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06497556

Population:

Adult

Phase:

III

The purpose of this study is to evaluate how well and how safely the experimental drug, divarasib, works compared to other approved drugs for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a mutation in the kirsten rat sarcoma virus (KRAS) G12C gene. This gene mutation drives cancer growth. The other approved treatments are sotorasib or adagrasib. The study drug, divarasib, is experimental, meaning it has not yet been approved by the U.S. Food and Drug Administration. While several drugs targeting this gene mutation have recently been developed, there is still...
A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD6008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation (TIAN-SHAN1)

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06813365

Population:

Adult

Phase:

I

This study is a Phase 1 clinical trial, which means it is the first stage of testing a new drug in humans to evaluate its safety, determine how the body processes it, and identify any potential side effects. The drug being studied, DZD6008, is investigational, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). This study is evaluating the study drug, DZD6008, in patients with advanced non small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation. EGFR is a protein that is important in regulating activities in cell proliferation...
A Phase 3, Open-Label, Randomized, Multi-Center Study ofDZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05668988

Population:

Adult

Phase:

III

The purpose of this study is to see how safe the study drug, DZD9008, is, how it works, and assess the efficacy of the study drug verse standard treatment of your disease. DZD9008 is an investigational drug that has not been approved by United States Food and Drug Administration (FDA), for the treatment of NSCLC. Pemetrexed combined with Carboplatin is the standard treatment for advanced non-small cell lung cancer (NSCLC) with Exon 20 Insertion Mutation. The EGFR (epidermal growth factor receptor) is a gene that regulates cell growth and this gene can change, or mutate, in some people with...

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