Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Pemetrexed

Cisplatin

Gefitinib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)

Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)

Placebo

Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles

Pemetrexed plusCIsplatin

Jin Soo Lee, M.D. PhD.

SUNG JIN YOON, RN

Sung Jin Yoon, RN

Jin Soo Lee, MD. Ph.D.

Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Investigators believe this PFS curve crossing-over in both IPASS and First-SIGNAL study is mainly due to early progression of EGFR mutation-negative tumors after gefitinib alone. Taken together with the FASTACT trial results, this PFS curve crossing-over may well be averted if effective chemotherapy is given together with gefitinib in a most optimum timing and sequence. Apparently, timing of EGFR-TKI administration within chemotherapy cycles is very critical, as shown in OSI 9774 trial.

In this placebo-controlled randomized phase II, Investigators propose to give gefitinib on days 5-18 of a 3-weekly chemotherapy cycle of pemetrexed/cisplatin to avoid any potential overlap of EGFR-TKI effects on chemotherapy or vice versa. Investigators would like to generate promising pilot data, which warrants a large phase III trial. Investigators hope to show that intercalated administration of Iressa® (gefitinib) and Pemetrexed/platinum regimen improves the outcome of never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

A Randomized Placebo-controlled Phase II Study of Intercalated Administration of Pemetrexed/Cisplatin With Iressa® (Gefitinib) or Placebo as First-line Treatment of Stage IIIB/IV Lung Adenocarcinoma in Never-smokers

from date of randomization until the date of first documented progression or death from any case.

Assessed minimum 1 years.

Participants will be followed for the duration of chemotherapy. CTCAE version 4.0

AstraZeneca

National Cancer Center, Korea

Principal Investigator

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carboplatin

LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies)

Dosing occurs on Day 1 of a 21-day cycle.

Pemetrexed and Carboplatin Only (standard of care chemotherapies)

Dosing occurs on Day 1 of a 21-day cycle.

LP-300: 18.4 g/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.

LP-300

Pemetrexed: 500 mg/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. After completion of the 4 to 6 cycles, patients will have the option to continue pemetrexed maintenance therapy until disease progression, unacceptable toxicity, or patient preference/physician discretion. The number of treatment cycles will be determined by PI discretion.

Carboplatin: area under the concentration-time curve 5 mg/mL per minute (AUC5) by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.

Lyza Trejo

Mini Gill

Kamalesh Sankhala, MD

Monica King

Eric Lee, MD

Susan Tieng

Nihal Abdulla, MD

Sandy Tran

Robert Hsu

Celeste Barker

Patricia Rich

John Lewandowski

Taylor Branch

Joseph Treat, MD

Adam Itano

Jonathan Dowell, MD

Christine Terraciano

Kartik Konduri, MD

Mahwish Bari

Janakiraman Subramanian, MD

Amin Benyounes, MD

David Lee, MD

Nagla Karim, MD

Reggie Ewesuedo, MD

The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.

Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs) will be eligible for enrollment. The trial will proceed in two stages. In the safety lead-in stage, 6 patients will be enrolled and treated with the LP-300 co-administered in combination with carboplatin and pemetrexed. In the absence of any safety signals in these patients, the second stage of the trial protocol will begin. This second stage consists of randomizing patients in a 2:1 allocation ratio to one of two arms: investigational arm of carboplatin, pemetrexed, and LP-300 or the standard of care arm of carboplatin and pemetrexed. Treatment of both groups will be on Day 1 of a 21-day cycle. A total of 4 to 6 treatment cycles are planned (number of cycles determined by PI discretion), with the possibility of patients going into a pemetrexed maintenance phase afterwards.

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (The HARMONIC Study)

Number of days or months from the date of randomization to the earliest of the documented disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria

Number of days or months between the randomization date and the date of death from all causes

Proportion of patients with the best overall response of complete response or partial response

Time when the complete response/partial response criteria are met (whichever is first recorded) until the first date that recurrent or progressive disease is documented

Proportion of patients with the best overall response of complete response or partial response or stable disease for at least 120 days

Lantern Pharma Inc.

Gemcitabine

Gefitinib 250mg table/QD, daily every 3 weeks

gemcitabine 1250mg/m2 iv on D1 \& D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks

gefitinib 250mg tablet/ QD daily until Progression

gemcitabine(1250mg/m2 iv on D1 \& 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles

chemotherapy

Jin Soo Lee, M.D.

The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as compared with the standard combination chemotherapy.

This is a randomized, open label, parallel group, phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung.

After stratification by gender, performance status, and disease stage, patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression, unacceptable toxicity or patient's refusal, whichever is sooner. The chemotherapy will be administered for no more than nine cycles.

Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks

standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3 week cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)

First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

A Randomized Phase III Study of Gefitinib (IRESSATM) Versus Standard Chemotherapy (Gemcitabine Plus Cisplatin) as First-line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers	NCT01502202	Non Small Cell ... Adenocarcinoma	Gefitinib Placebo Pemetrexed plus...	18 Years -	National Cancer Center, Korea
A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma	NCT05456256	Adenocarcinoma ... Carcinoma, Non-...	LP-300 Pemetrexed Carboplatin	18 Years -	Lantern Pharma Inc.
First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker	NCT00455936	Lung Cancer	Gefitinib chemotherapy	18 Years - 75 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for never smoker

Every month we try and update this database with for never smoker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.