Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab will be given intravenously on Day 1 of the 21 day cycle (For all cycles).

GT103 dose will be determined by the safety lead in prior to the study. Dosing calculations should be based on actual body weight where applicable. It will be taken intravenously on Day 1 of the 21 day cycle (For all cycles).

10mg/kg taken intravenously on Day 1 of cycle.

GT103

Jeffrey Clarke, MD

This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. A total of 50 patients will be treated with the combination at the safest dose of GT103 as determined in the safety lead-in. If 10 additional patients are enrolled to the dose level -1 then the maximum of 60 subjects may be accrued to this trial.

Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer

A Phase II Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer

ORR will be defined as the proportion of patients with radiographic complete or partial response rate per RECIST v1.1.

Safety and tolerability will be assessed by the proportion of patients with DLT observed during the first cycle of treatment. NCI CTCAE v5 will be used to grade adverse events.

The time for the concentration of GT103 to reach half of the level administered when given in combination with Pembrolizumab (T1/2) will be measured by pharmacokinetic analysis.

The time it takes GT103 to reach maximum concentration when administered with Pembrolizumab will be measured by pharmacokinetic analysis.

The maximum concentration (Cmax) of GT103 in the serum after administration in combination with Pembrolizumab will be measured by pharmacokinetic analysis.

Area under the plasma concentration vs time curve (AUC) for GT103 will be measured by pharmacokinetic analysis.

PFS is defined as the time between initiation of treatment and progression by RECIST 1.1 or death.

OS is defined as the time between initiation of treatment and death from any cause.

Merck Sharp & Dohme LLC

Grid Therapeutics

Jeffrey Clarke

Sponsor Investigator

Antirheumatic Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Nivolumab

Interleukin-2

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Analgesics, Non-Narcotic

Nivolumab infusion every 3 weeks prior to lymphodepletion chemotherapy with cyclophosphamide/fludarabine, TIL infusion and interleukin-2. Then nivolumab infusion every 4 weeks up to 12 months.

Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.

Tumor-infiltrating Lymphocytes (TIL)

Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.

Cyclophosphamide will be administered on days -7 and -6.

Fludarabine will then be infused per institutional standard on Days -7 to -3.

On day 0, all patients will receive a dose infusion TIL cells.

Tumor-infiltrating Lymphocyte Therapy

Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.

Interleukin-2 (IL2)

Ben Creelan

Tanner Pearson

Ben Creelan, MD, MS

Daniel Abate Daga, PhD

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)

To characterize the safety profile of CD40L-augmented TIL administered with nivolumab.

Proportion of patients with complete response + partial response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

The time from the date of the first documentation of initial response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause.

The time length of patients living from the date of TIL infusion

H. Lee Moffitt Cancer Center and Research Institute

Anti-Infective Agents

Micronutrients

Hematinics

Vitamins

Pemetrexed

Itraconazole

Hydroxyitraconazole

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Clotrimazole

Miconazole

Antifungal Agents

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Folinic Acid

Folate

Vitamin B9

Pemetrexed IV every 21 days with oral Itraconazole 200mg daily.

Charles M Rudin, MD, PhD

Primary Objective

To evaluate the 3-month event-free survival of the combination of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.

Secondary Objectives

To determine the objective response rate of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.

Primary Objective

To evaluate the 3-month event-free survival of the combination of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer. 3-month event-free survival (EFS) is defined as the proportion of patients who are alive and without event after 3 months (evaluated in a window of +/- 1 week) of treatment. Events are defined as disease progression or death from any cause. All patients treated on protocol will be included in the determination of EFS, regardless of treatment modification or discontinuation.

Secondary Objectives

To determine the objective response rate of the combination of itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous NSCLC

A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer

Number of participants with partial response (PR), stable disease (SD) and progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Tumor blood flow activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.

Tumor metabolic activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).

Itraconazole: Itraconazole 200 mg once daily

Itraconazole Open Label Added to Standard of Care Pemetrexed

Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.

Pemetrexed

Single Agent Pemetrexed

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Charles Rudin, MD

Arm A

Arm B

Overall Survival

Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.

Progression Free Survival as Measured by Number of Days Without Disease Progression

Inevaluable

RECIST Response

Data was not collected to assess this outcome measure.

Tumor Blood Flow

Tumor Metabolic Activity

Overall Study

Neoplasm Metastasis

Lazertinib

Amivantamab-vmjw

Protein Kinase Inhibitors

All patients in both cohorts will receive both oral lazertinib and amivantamab by intravenous injection (IV). Lazertinib dosing will start at 240 mg daily. For patients who weigh \<80 kg, on C1D1 amivantamab 350 mg will be given IV via peripheral line for C1D1, D2 and D8, with 700 mg IV given on C1D2. For all other treatments, amivantamab 1050 mg IV will be given. For patients who weigh ≥ 80 kg, on C1D1 350mg IV amivantamab will be given and 1050 mg IV on C1D2, with 1400 mg IV given for all.

Amivantamab 1050mg IV once weekly for the first 28 days (Cycle 1) and every other week thereafter. For subjects who weigh ≥80 kg, they will receive 350mg IV on C1D1 and 1050 mg on C1D2. They will continue to receive amivantamab 1400 IV once weekly for the first 28 days and every other week thereafter. Each cycle is 28 days in length.

Amivantamab

Lazertinib 240 mg orally once daily and take this continuously, starting C1D1. For patients who weigh \<80 kg, on C1D1, patients will receive amivantamab 350 mg IV, with 700 mg given on C1D2.

Helena Yu, MD

The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation. Both drugs work to target cancer cells with an EGFR mutation, and this targeting action could stop or slow the growth of cancer cells. The researchers are doing this study to find out how well amivantamab and lazertinib work against metastatic NSCLC with an EGFR mutation.

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Single-Arm Study of Amivantamab (JNJ-61186372) and Lazertinib in Metastatic EGFR-mutant Lung Cancer With Progressive or New CNS Metastases on Previous Treatment

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with EGFR-mutant lung cancer with progressive or new parenchymal brain metastases. RANO-BM will be used when 5-9MM and RECIST 1.1 when 1cm or greater.

Per modified Response Assessment in Neuro-Oncology (RANO-LM) and systemic ORR by RECIST v1.1 in patients with EGFR-mutant lung cancer and progressive or new leptomeningeal disease

Janssen Scientific Affairs, LLC

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

Vinorelbine

Tubulin Modulators

Antimitotic Agents

Patients will take three times a week \[Monday, Wednesday and Friday\] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure

vinorelbine oral formulation

Evangelos Briasoulis, MD

Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three times a week: on Monday, Wednesday and Friday.

The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. \[Metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods\]. Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.

Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

University of Ioannina

Hellenic Cooperative Oncology Group

Evangelos Briasoulis

Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy.

Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy along with continuous physical activity monitoring via a wearable device.

Activity tracker that is worn on the wrist.

Garmin Vivofit Activity Tracker

Nitin Ohri, MD

Nicole Imamovic

Amit Shah, MD

Nicole Imamovic, RN,OCN,CCRP

This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment.

PRIMARY OBJECTIVE:

To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course.

SECONDARY OBJECTIVES:

I. To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial.

II. To examine the association between baseline activity level and clinical outcomes related to treatment tolerance, quality of life, chemoradiotherapy adverse events, and physical function preservation.

III. To demonstrate associations between daily step counts and short-term hospitalization risk.

IV. To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters.

EXPLORATORY OBJECTIVES:

I. To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer.

II. To examine the association between baseline activity level with progression free survival and overall survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Usual Care

ARM II: Usual Care + Continuous physical activity monitoring via a wearable device.

Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy.

Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer

Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC)

Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.

Occurrence of emergency room visit lasting more than 24 hours during radiation treatment or within 1 month after radiotherapy completion.

Occurrence of of radiation treatment interruption (missing two or more treatments, not due to machine issues or scheduled holidays) during radiation treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer	NCT05617313	Non Small Cell ... Metastatic NSCL... Recurrent Non S...	Pembrolizumab GT103	18 Years -	Duke University
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC	NCT05681780	Non Small Cell ... Stage IV Non-sm... Recurrent Non S...	Tumor-infiltrat... Nivolumab Cyclophosphamid... Fludarabine Tumor-infiltrat... Interleukin-2 (...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous NSCLC	NCT00769600	Recurrent Non S...	Itraconazole Pemetrexed	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)	NCT04965090	Metastatic Non ... Recurrent Non S...	Amivantamab Lazertinib	18 Years -	Memorial Sloan Kettering Cancer Center
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors	NCT00278070	Breast Cancer Non Small Cell ... Prostate Cancer	vinorelbine ora...	16 Years - 75 Years	Hellenic Cooperative Oncology Group
Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer	NCT04878952	Non-small Cell ... Non-small Cell ... Recurrent Non S...	Garmin Vivofit ...	18 Years -	NRG Oncology
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)	NCT04965090	Metastatic Non ... Recurrent Non S...	Amivantamab Lazertinib	18 Years -	Memorial Sloan Kettering Cancer Center

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