Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Almonertinib, 110 mg, po, QD; 28 days every cycle

Almonertinib

Zhou Chengzhi, MD

Chengzhi Zhou, Professor

Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore, the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.

Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.In recent years, systemic treatments with good efficacy and low toxicity, such as gene-targeted therapy, anti-angiogenic therapy and immunotherapy, have largely replaced single chemotherapy, and have great potential to benefit from existing treatments for poor PS scores of advanced lung cancer patients can adopt more aggressive treatment strategies.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore,the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.

Single Group Assignment Almonertinib monotherapy

Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

Exploration of the Clinical Application of Almonertinib in the First-line Treatment of Patients With EGFR Mutation-positive Advanced Non-small Cell Lung Cancer With Poor Performance Status

Time of performance status score change from 2\~4 to 1

Guangzhou Institute of Respiratory Disease

Director, Head of pneumology department, Principal Investigator, Clinical Professor

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

gemcitabine

cisplatin

Cesare Gridelli, M.D.

Luciano Frontini, M.D.

Vittorio Gebbia, M.D.

Andrea Ardizzoni, M.D.

Filippo de Marinis, M.D.

Enrico Aitini, M.D.

Francesco Perrone, M.D., Ph.D.

Ciro Gallo, M.D., Ph.D.

The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.

Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy is recommended for advanced NSCLC patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). This category of patients represents about 20% of all patients at initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. Studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

Clinical Trials Promoting Group (APRIC/CTPG)

Gruppo Oncologico del Lazio (GOL)

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC)

Gruppo Oncologico Italia Meridionale

Northwest Oncology Cooperative Group(GONO)

National Cancer Institute, Naples

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All patients will be given daily oral afatinib (BIBW 2992) administered every 28 days until disease progression/toxicity/clinician decision to stop. Starting dose is 40mg. 30mg and 20mg will be administered according to protocol dose modification requirements following toxicity.

Afatinib (BIBW 2992)

Sanjay Popat, BSc MBBS MRCP PhD

The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.

Lung cancer is most common cause of death from cancer, of which non-small cell lung cancer (NSCLC) accounts for \~80% of all cases with most patients presenting with advanced disease. Patients medically unfit to receive radical or platinum-doublet palliative systemic therapy, because of poor performance status or comorbidity, account for at least 45% of newly diagnosed cases and have poor survival. Many oncologists have interpreted single-agent chemotherapy data as not clinically meaningful when balanced against toxicities, non-significant improvements in quality of life and comorbidity. Hence, in the UK, this group of patients are predominantly treated by best-supportive care (BSC).

This study aims to examine the efficacy and safety of using afatinib (BIBW 2992), an irreversible second generation EGFR inhibitor, in patients with non-small cell lung cancer, who are considered unfit for chemotherapy and have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.

Suspected EGFR mutant patients will have clinical characteristics likely to harbour the EGFR mutation (adenocarcinoma sub type and ex or never smokers) with EGFR genotype unknown either due to no tissue suitable for genotyping or failed genotype.

There has been only one small prospective study of medically unfit patients with EGFR mutation, but it demonstrated good efficacy with a TKI17. This phase II study of East Asian patients (n=30) with performance status 2-4 and treated with gefitinib demonstrated a rapid improvement in performance status at 1 month, an overall response rate of 66% and median survival of 17.8 months. Whilst gefitinib is licensed for EGFR mutant NSCLC, no prospective studies have yet been performed on medically unfit patients from Western countries. Despite dramatic initial responses, EGFR mutant NSCLC patients treated with gefitinib/erlotinib ultimately relapse. In \~50% of cases this is due to the gefitinib/erlotinib-resistant T790M genotype acquired through either secondary somatic mutation or clonal expansion. There is therefore a need to improve the outcomes of medically unfit patients with suspected EGFR mutation, who would otherwise be treated with best supportive care, and in proven EGFR mutation cases by using an effective EGFR-directed therapy that inhibits EGFRT790M.

Prospective data on medically unfit Western NSCLC patients with EGFR mutation are required to assess the efficacy of EGFR-TKIs. Additionally, given that 50% of such patients will become TKI-resistant through EGFRT790M, new therapies are required to overcome this resistance mechanism.

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Trial of Afatinib (BIBW 2992) in Suspected or Confirmed Mutant EGFR Lung Cancer Patients Unfit for Chemotherapy

Progression free survival will be determined by measurement of tumour size using RECIST version 1.1 at progression or date of patient death.

For each type of adverse event, the maximum toxicity grade will be obtained for each patient using CTCAE version 4.0 to closely monitor tolerability to BIBW 2992. Focus will be on those with a grade 3 or 4 BIBW 2992 related toxicities. The proportion of patients with any grade 3 or 4 event will also be examined.

Boehringer Ingelheim

University College, London

Symptoms and General Pathology

Heart and Blood Diseases

Neoplasm Metastasis

Pleural Effusion, Malignant

Pleural Effusion

Pericardial Effusion

Micronutrients

Hematinics

Vitamins

Pemetrexed

Folic Acid Antagonists

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Alimta 500 mg/m\^2 by vein Once Over 10 Minutes Every 3 Weeks.

500 mg/m\^2 by vein Once Over 10 Minutes Every 3 Weeks

Alimta

Ralph Zinner, MD

The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS) (inability to perform every day activities without difficulty).

Objectives:

Primary Objectives:

* PS = 2 cohort: Response
* PS = 3 cohort: Descriptive

Secondary Objectives:

* Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients
* Improved symptoms (both cohorts)
* Molecular Correlative studies (both cohorts)
* Overall survival
* Time to progression

Pemetrexed is designed to block enzymes in the body that are important for tumor growth. Pemetrexed is commercially approved for the treatment of NSCLC but not for poor performance status patients.

If participants are found to be eligible to take part in this study, they will receive pemetrexed once every 3 weeks through a needle in their vein over about 10 minutes. Every 3 weeks is considered 1 treatment cycle. Once the treatment has started, they will return to the clinic before every treatment cycle. At these visits, they will have a physical exam, a performance status evaluation, and routine blood (about 3-4 teaspoons) and urine tests. They will have a chest x-ray and will be asked to complete a questionnaire about how you are feeling. they will also have a CT or MRI scan after Cycle 1 and every odd cycle from then on.

They are required to take folic acid by mouth every day for 5 days before the first dose of pemetrexed and continuing until 3 weeks after your last dose of pemetrexed. They will also receive an injection of vitamin B12 into your muscle before first dose of pemetrexed. The vitamin B12 injection will be repeated every 9 weeks until 3 weeks after their last dose of pemetrexed.

They will also to take a few low-dose steroid (dexamethasone) tablets twice a day before treatment, the day of treatment, and the day after each treatment. These will be taken to decrease the risk of rash and nausea caused by pemetrexed.

They may continue treatment with pemetrexed until your tumor grows or an unacceptable side effect occurs. They will be evaluated for symptoms 1-2 times per week while you are receiving treatment and then 2 weeks after stopping study treatment until 6 months after stopping treatment.

When they stop treatment on this study, they will have a physical exam, routine blood (3-4 teaspoons) and urine tests, and a chest x-ray. The study doctor may ask them to visit University of Texas MD Anderson Cancer Center or be contacted by phone for follow-up on how they are doing.

This is an investigational study. The FDA has approved pemetrexed for the treatment of advanced NSCLC after earlier treatment with chemotherapy, and for the treatment for malignant mesothelioma in combination with cisplatin. About 70 patients will take part in this study. All will be enrolled at MD Anderson.

Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer

Single Agent Alimta in Poor Performance Status in Patients With Non-Small Cell Lung Cancer (NSCLC)

Complete Response (CR): Complete disappearance of all measurable \& non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers \& other abnormal lab values.

Partial Response (PR): Applies only to those with at least one measurable lesion. \>/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.

Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician.

Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles).

Eli Lilly and Company

M.D. Anderson Cancer Center

Alimta 500 mg/m\^2 by vein once over 10 minutes every 3 weeks.

Age, Continuous

Gender

United States

Region of Enrollment

Ralph Zinner, MD/Thoracic & Head and Neck Medicine

Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.

Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status	NCT05826483	Malignant Tumor... Poor Performanc...	Almonertinib	18 Years -	Guangzhou Institute of Respiratory Disease
CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients	NCT00526643	Non-Small Cell ...	gemcitabine cisplatin	18 Years - 70 Years	National Cancer Institute, Naples
CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients	NCT00526643	Non-Small Cell ...	gemcitabine cisplatin	18 Years - 70 Years	National Cancer Institute, Naples
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients	NCT01415011	Carcinoma, Non-...	Afatinib (BIBW ...	18 Years -	University College, London
Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer	NCT00508144	Lung Cancer	Alimta	18 Years -	M.D. Anderson Cancer Center
Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer	NCT00508144	Lung Cancer	Alimta	18 Years -	M.D. Anderson Cancer Center
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients	NCT01415011	Carcinoma, Non-...	Afatinib (BIBW ...	18 Years -	University College, London

Spots Global Cancer Trial Database for poor performance status