Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.

Pilar Garrido, MD

This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.

The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.

Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The standard treatment in unresectable patients was chemoradiotherapy consurrently if possible.

The PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemotherapy and thoracic RT. The study was positive for both primary endpoints progression-free survival and overall survival. After that, it was decided to open an early acces programme ti provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) tho have not progressed following chemoradiation.

This observational study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world.

The study will include all patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.

The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Other secondary objectives are:

To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration of therapy and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.

Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.

Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.

To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS

To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.

To describe AESIs leading to treatment temporary interruption or permanent discontinuation of durvalumab, or which require interventions of concomitant use of corticosteroids, immunosupressants and/or endocrine therapies.

To estimate time and sites of disease progression or relapse in metastatic setting.

Fundación GECP

Digestive System Diseases

Skin and Connective Tissue Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma, Hepatocellular

Sarcoma

Melanoma

Sarcoma, Alveolar Soft Part

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Alveolar Soft Part Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Immunomodulating Agents

Atezolizumab

Immune Checkpoint Inhibitors

Atezolizumab administered via IV at either 1,200 mg q3 weeks, or 1,680 mg q4 weeks for the first 2 doses followed by 850mg q2 weeks or q6 weeks.

NCI Medical Oncology Referral Office

James L Gulley, M.D.

National Cancer Institute Referral Office

Background:

A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects.

Objective:

To test different doses and timing of atezolizumab for people with cancer.

Eligibility:

People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug.

Design:

Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor.

Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care.

The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later.

For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change.

Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months.

Study treatment may last up to 2 years.

Background:

* The treatment of many cancers has been revolutionized through the use of monoclonal antibody immune checkpoint inhibitor drugs, particularly those that block the interaction of the anti-programmed death-ligand 1 (PD-L1) with the programmed death-1 (PD-1) receptor.
* Atezolizumab was initially tested in a phase 1a multicenter, dose-escalation, and dose- expansion study (NCT01375842) which showed that the drug was well tolerated and produced clinical responses in a variety of tumors.
* The initially approved atezolizumab regimen was 1,200 mg every 3 weeks, but 840 mg every 2 weeks was added based on the data from the TNBC trial (NCT01375842). This was taken further by Morrissey et al., who used population pharmacokinetic (PK) simulations to determine that dosing regimens of 840 mg every 2 weeks and 1,680 mg every 4 weeks are interchangeable with 1,200 every 3 weeks in terms of efficacy, leading the Food and Drug Administration (FDA) to expand the dosing regimens for atezolizumab.
* The standard dosing regimens yield steady-state concentrations greater than 10-fold above the stated minimum effective concentration of 6 g/mL, to ensure adequate exposure for all patients, including patients that may experience lower exposure due to the incidence of anti-drug-antibodies (ADA). Atezolizumab exhibits a flat exposure- response relationship.

Objective:

-To test the feasibility of reducing drug exposure while maintaining plasma drug concentration at or above the expected target trough value during a 16-week study period by using a method for therapeutic drug monitoring of atezolizumab.

Eligibility:

* Age \>= 18 years old.
* Participants with a locally advanced or metastatic cancer who are candidates for treatment with atezolizumab, either alone or in combination with other FDA-approved drug(s).
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
* Adequate organ and marrow function.

Design:

* This is a phase I feasibility study of a therapeutic drug monitoring (TDM)-based method for atezolizumab dosing.
* The participants will start with FDA approved dose and frequency of atezolizumab (840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks) selected by their treating physician for the first two doses of the drug per standard of care.
* After the second dose, starting at 3rd dose, the dose of the drug will be switched to 840 mg and will be used going forward in the trial in all participants.
* Prior to each dose, starting at the 2nd dose, a trough will be drawn which will be by the population PK model to predict the timing of the next dose to maintain the atezolizumab target trough for each participant specifically. This will be repeated for the first 16 weeks of treatment.
* After 16 weeks of treatment, the timing of the next dose to maintain the atezolizumab target trough for each participant will be monitored and adjusted (if necessary) every 3 months for each participant until 2 years.

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

The fraction of participants that can be dosed with 840mg of atezolizumab at less frequent intervals while maintaining a trough PK concentration at or above 6 mg/mL

PK evaluations before every atezolizumab infusion starting from the second dose until 16 weeks after atezolizumab treatment and every 3 months after 16 weeks on treatment.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.	NCT04285866	Small Cell Lung...	Durvalumab	18 Years -	Fundación GECP
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing	NCT06066138	Locally Advance... Metastatic Alve... Locally Advance... Metastatic Non ... Locally Advance... Metastatic Smal... Locally Advance... Metastatic Hepa... Locally Advance... Metastatic Mela...	Atezolizumab	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing	NCT06066138	Locally Advance... Metastatic Alve... Locally Advance... Metastatic Non ... Locally Advance... Metastatic Smal... Locally Advance... Metastatic Hepa... Locally Advance... Metastatic Mela...	Atezolizumab	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing	NCT06066138	Locally Advance... Metastatic Alve... Locally Advance... Metastatic Non ... Locally Advance... Metastatic Smal... Locally Advance... Metastatic Hepa... Locally Advance... Metastatic Mela...	Atezolizumab	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for locally advanced small cell lung cancer