Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Once daily without interruption as long as there is no disease progression or serious side effects experienced.

OSI-774 (Tarceva)

Pasi A Janne, MD, PhD

The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle.

Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study.

Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning.

Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle.

Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Massachusetts General Hospital

Brigham and Women's Hospital

Genentech, Inc.

Dana-Farber Cancer Institute

Associate Professor, Medicine

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Immune Checkpoint Inhibitors

Immunomodulating Agents

Antineoplastic Agents, Immunological

All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.

immune-checkpoint inhibitors therapies

Dominique GENRE, MD

Margot BERLINE, MSc, MBA

Elodie Crétel

Renaud SABATIER, MD

Pierre SOUBEYRAN, Dr

Christelle LEVY, Dr

Christelle LEVY

Leila BENGRINE-LEFEVRE

Laurence CRISTOL, MD

Michaël BRINGUIER, Dr

Emmanuelle BOURBOULOUX, MD

Loïc MOUREY, Dr

Renaud Sabatier, MD

The co-primary objectives will be to assess the safety and quality of life under treatment.

The co-primary objectives will be to assess the safety and quality of life under treatment. Secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens.

Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population.

Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.

This is a national prospective phase 4, multi-centre, single arm, open-label cohort study to evaluate the safety and efficacy of immune checkpoint inhibitors-based therapies in elderly patients with advanced or metastatic melanoma or NSCLC.

Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies

Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial

Description of adverse events' type, incidence, severity (CTCAE v.5.0), timing, seriousness, and relatedness. This endpoint will be based on the rate of grade ≥ 3 adverse events 18 weeks after treatment initiation, defined as medical assessment of safety including adverse events' type, incidence, severity (graded by the CTCAE\] v. 5.0), timing, seriousness, and relatedness. This will include clinical as well as biological toxicities such as liver and endocrine dysfunctions. All high grade adverse events will be taken into account.

Quality of life will be evaluated using the EORTC QLQ-C30 and QLQ-ELD14 questionnaires collected at inclusion and at every treatment cycles during the first 6 weeks, then every 6 weeks until treatment discontinuation. The proportion of patients with a decrease superior or equal to 10% for their global score between baseline and at 24 weeks after treatment initiation will be estimated.

Geriatric data assessment will be done at inclusion and every 6 weeks until treatment discontinuation. Exhaustive data will be collected at inclusion. The investigators will also assess the G-CODE (Geriatric Core Dataset), a recently described minimum geriatric data set (see SOFOG guidelines). G-CODE assessment will be repeated every 6 weeks during treatment and at treatment discontinuation. These data will be collected either by the geriatrician or trained clinical research nurses during geriatric consultation as part of geriatric follow-up, an integral part of the patient management.

Reminder of CTCAE version 5.0 will be completed by clinicians before every treatment cycle. Patients will also complete a language adapted version of patient-reported outcome PRO-CTCAE questionnaire. For all symptoms, the investigators will measure the proportion of pairs for which clinicians and patients gave an identical grade. The investigators will also measure the proportion of pairs that will disagree for each symptom by one point (e.g., patient grade 2 and clinician grade 1), and the proportion that will disagree by two or more points (e.g., patient grade 2 and clinician grade 4). The investigators will also record the number of symptoms for which each pair agreed.

Evaluation of Progression-free Survival (PFS) will be defined as the time from treatment beginning to radiological (according to the RECIST 1.1 criteria) or clinical progression of the disease as declared by the investigators, or death of any cause. Radiological evaluations will be performed every 6 weeks.

Overall Survival (OS) will be defined as the time from treatment beginning to death of any cause.

Correlation between occurrence of auto-immune adverse events (with a landmark time at week 18) and efficacy (PFS).

Safety profiles comparison according to treatment regimen (PD1-inhibitor monotherapy vs PD1- inhibitor/CTLA4-inhibitor combination vs CTLA-inhibitor monotherapy vs PDL1-inhibitor if available at time of trial beginning) will be performed by looking at the rate of grade 3 to 5 adverse events 18 weeks after treatment initiation for each therapy.

Société Francophone d'Onco-Gériatrie

Institut Paoli-Calmettes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients	NCT00137800	Non-Small-Cell ...	OSI-774 (Tarcev...	70 Years -	Dana-Farber Cancer Institute
Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies	NCT03673332	Advanced or Met... Advanced or Met...	immune-checkpoi...	70 Years -	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for elderly cancer patients