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SWOG 1827: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Principal Investigator:

Simon K. Cheng, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04155034

Population:

Adult

Phase:

III

We are doing this study because we want to find out if MRI brain scans alone is better or worse than MRI brain scans plus preventative brain radiation for patients with small lung cancer. The usual approach for patients with small cell lung cancer is prophylactic cranial irradiation. If you decide to take part in this study, you will either receive PCI for two weeks and brain MRIs for two years, or you will just receive brain MRIs for two years. Are you Eligible? (Inclusion Criteria) To be included in this study, you must: have diagnosis of small-cell lung cancer (SCLC) confirmed by pathology...
A Randomized, Double-Blind, Placebo-Controlled Trial ofTomivosertib in Combination With Anti-PD-(L)1 Therapy inSubjects With Non-Small Cell Lung Cancer as First-Line Therapyor When Progressing on Single-Agent First-LineAnti-PD-(L)1 Therapy

Principal Investigator:

Brian Henick, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04622007

Population:

Adult

Phase:

II

The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allow tumor cells to grow and go unnoticed by your immune system. This study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects with Non-Small Cell Lung Cancer. There are two study arms for this study. Treatment arm A, in addition to taking study drug you will continue to receive pembrolizumab as either 200 mg by infusion at every...
A Randomized, Open-label Phase 3 Study of Combination Amivantamab andCarboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFRExon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04538664

Population:

Adult

Phase:

III

The purpose of this study is to see if amivantamab in combination with administration of standard of care chemotherapy (carboplatin and pemetrexed) is safe and useful for treating patients with Non Small Cell Lung Cancer, specifically in patients with a gene abnormality called EGFR Exon 20 insertions. There are two study arms for this trial. Patients on Study Treatment Arm A will receive the investigational drug (amivantamab) in addition to standard of care chemotherapy and Study Treatment Arm B will only receive standard of care chemotherapy. Some procedures involved with the study include...
NAUTIKA1: MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF ALECTINIB, ENTRECTINIB, VEMURAFENIB PLUS COBIMETINIB, OR PRALSETINIB IN PATIENTS WITH RESECTABLE STAGES II-III NON-SMALL CELL LUNG CANCER WITH ALK, ROS1, NTRK, BRAF V600, OR RET MOLECULAR

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 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small CellLung Cancer

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT02609776

Population:

Adult

Phase:

I

1. Are you at least 18 years old? 2. Do you have confirmed unresectable metastatic non-small cell lung cancer? Are you Eligible? (Inclusion Criteria) The purpose of this study is to see if the study drug, JNJ-61186372, is safe and useful for treating patients with advanced, metastatic, non-small cell lung cancer. There are 2 parts of this study. The first part is to determine the dose of JNJ-61186372 that is safe to give to patients with non-small cell lung cancer. The second part of the study is to gather more information about safety and determine if JNJ-61186372 might be effective for your...
An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937(Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations WithJNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04077463

Population:

Adult

Phase:

I

The purpose of this study is to see if lazertinib and JNJ-61186372 are safe and useful for treating patients with a type of lung cancer called advanced non-small cell lung cancer (NSCLC) as well as looking at the effects that lazertinib and JNJ-61186372 have when taken together. Lazertinib is taken orally and JNJ-61186372 is an intravenous drug. Lazertinib (YH25448) belongs to a class of drugs called EGFR tyrosine kinase inhibitors, which helps slow the growth or stop the cancer cells. JNJ-61186372 is an antibody. Antibodies are proteins that bind to certain targets. In test tubes and animals...
An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03909334

Population:

Adult

Phase:

II

The purpose of this study is to compare the usual treatment for Non-Small Cell Lung Cancer (osimertinib) to a combination therapy (osimertinib plus ramucirumab). The combination therapy arm is testing if ramucirumab can help osimertinib control the abnormal EGRG protein for a longer time and keep the disease inactive longer. EGRF protein typically helps the cell grow and divide and some subjects with Non- Small Cell Lung Cancer (NSCLC) have too much of this protein causing the cancer to grow faster. Osimertinib is an FDA approved drug that helps shrink the tumor by blocking the EGRF protein...
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 Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell LungCancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD)

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03944772

Population:

Adult

Phase:

II

The purpose of this study is to gain a better understanding of why some patients with non-small sell lung cancer and a epidermal growth factor receptor (EGFR-sensitizing mutation, fail first-line treatment with the drug osermitinib. Additionally, the purpose is to explore different drug therapies for patients whose cancer has progressed (gotten worse) after treatment with osermitinib, and to evaluate each therapy's safety and how effective each is at treating cancer. Each patient will be evaluated for mutations that might have made them resistant to osermitinib. Patients with certain...
A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD-1)

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04385368

Population:

Adult

Phase:

III

This study is aimed at finding patients who have small amounts of cancer DNA in their blood (called circulating tumor DNA or ctDNA) after surgery. This may indicate that you have minimal residual disease (MRD), meaning that even after surgery, there are still some remaining cancer cells releasing cancer DNA into your bloodstream. MRD after surgery may mean that the risk of cancer coming back is higher, which is why we would like to give additional treatment after your tumor has been removed. The study is focusing on subjects with stage II-III non- small cell lung cancer (NSCLC) that is being...

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