Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Durvalumab

Antineoplastic Agents, Immunological

Durvalumab 1500 mg every 4 weeks until the progression of disease, discontinuation due to toxicity or withdrawal of consent, for a maximum duration of 2 years.

Valérie GOUNANT

Michael DURUISSEAUX

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS \>3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

Immunotherapy in Patient With Poor General Condition

A Phase II Single-arm Trial Evaluating Safety and Efficacy of Durvalumab in ECOG Performance Status 2-3, Treatment-naive, Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) and High PD-L1 Tumor Expression

The maximum grade will be summarized by frequency and proportion of total patients, by system organ class and NCI-CTC, Version 5.0 categories.

Percentage of patients with objective response or stable disease according to RECIST 1.1 in the intent to treat population

Percentage of patients with objective response according to RECIST 1.1 in the intent to treat population

Time between the date of durvalumab initiation and the first date of documented progression or death due to any cause, whichever occurs first.

Time between the date of durvalumab initiation and the date of death due to any cause, whichever occurs first.

Proportion of per-protocol patients whose PS during durvalumab treatment was improved from baseline

EORTC QLQ-C30 +LC13 (Qualify of Life Questionnaire C30 + Lung Cancer 13) questionnaire

EQ-5D (EuroQol 5 Dimensions) questionnaire

Spots Global Cancer Trial Database for poor general condition