Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Death

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

1500 mg of durvalumab will be administered intravenously (IV) on day 1 of every 28 day cycle.

A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)

durvalumab

Liza Villaruz, MD

This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1 inhibitor durvalumab as first-line therapy in 47 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).

Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous (IV) administration. Durvalumab will be administered at 1500 mg (fixed dose) every 4 weeks until disease progression, death, unacceptable toxicity or withdrawal of consent for a maximum of 12 months of therapy.

A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

A Phase II Clinical Trial Evaluating the Safety and Efficacy of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

Individual participant data that underlie the results reported in this article after deidentification, in addition to the Study Protocol, will be available immediately following publication. Investigators whose proposed use of the data has been approved by an independent review committee may access the data to achieve aims in the approved proposal. Proposals should be directed to villaruzl@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication.

Median length of time from the start of treatment from start of treatment to death from any cause.

Number of patients alive at 12 months post start of treatment.

Number of patients alive at 24 months post start of treatment.

Number of participants with ≥ Grade 3 adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 that are at least possibly related to study treatment.

Median duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Number of patients without progressive disease or death at 12 months from start of treatment. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Number of patients without progressive disease or death at 24 months from start of treatment Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Number of patients of know PD-L1 status without progressive disease or death at 12 months from start of treatment. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Number of patients of know PD-L1 status without progressive disease or death at 24 months from start of treatment Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Number of patients with know PD-L1 status that are alive at 12 months post start of treatment.

Number of patients with know PD-L1 status that are alive at 24 months post start of treatment.

Percentage of patients with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0, for target lesions: PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: at least a 20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Percentage of patients with PD-L1 expression status = 0, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Percentage of patients with PD-L1 expression status=0%\<PD-L1\<50%, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Percentage of patients with PD-L1 expression status ≥50%, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

The FACT-LCS is the lung cancer subscale of the FACT-L. LCS includes the average symptom burden index (ASBI; based on 5 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (2-IGI; symptom distress, interference with activities, and health-related quality of life). Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-28. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

AstraZeneca

Academic Thoracic Oncology Medical Investigators Consortium

Assistant Professor of Medicine, Division of Hematology Oncology

Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03

Durvalumab: 1500 mg administered intravenously (IV) on Day 1 of every 28 day cycle

Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Smoking Status

Histology

Eastern Cooperative Oncology Group (ECOG) Performance Status. The ECOG PS scale indicates increasing levels of disability, with 0 indicating fully active; 1, restricted in strenuous activity; 2, restricted in work activity but ambulatory and capable of self-care; 3, capable of limited self-care; 4, completely disabled; and 5, dead.

ECOG Performance Status = 2

Stage II: divided into stage IIA and IIB, depending on size of the tumor, where it is found, and whether or not the cancer has spread to lymph nodes. Tumors may be larger than those in stage I and/or have begun to spread to nearby lymph nodes. Cancer not spread to distant organs. Stage III: classified as stage IIIA, IIIB or IIIC, depending on the size and location of the tumor and how far it has spread. Most commonly the cancer has spread to the lymph nodes in the mediastinum (area between lungs). Stage IV: most advanced; cancer metastasized to lining of the lung or other areas of the body.

Disease Stage

Barbara Stadterman, Regulatory Specialist Supervisor

Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Overall Survival (OS)

Overall Survival (OS12)

Overall Survival (OS24)

Patients that received study at least one cycle of treatment.

Treatment-related Adverse Events ≥ Grade 3

Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) at 12 Months

Progression-Free Survival (PFS) at 24 Months

PD-L1=0

0%<PD-L1<50%

PD-L1≥50%

Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 status is known.

Progression-Free Survival (PFS) by PD-L1 Expression at 12 Months

Progression-Free Survival (PFS) by PD-L1 Expression Status at 24 Months

Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 is known.

Overall Survival by PD-L1 Expression Status at 12 Months

Overall Survival by PD-L1 Expression Status at 24 Months

Partial Response (PD)

Stable Disease (SD)

Progressive Disease (PD)

Treated patients that are evaluable for radiologic response.

Overall Response Rate (ORR)

Partial Response

Stable Disease

Progressive Disease

Treated patients that are radiologically evaluable and for whom PD-LI status is known.

Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0

Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0%<PD-L1<50%.

Overall Response Rate (ORR) in Patients With PD-L1 Expression Status ≥50%

Treated patients that completed Health Related Quality of Life (HRQL) - FACT-G questionnaire.

Health Related Quality of Life (HRQL) - FACT-G

Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire.

FACT Lung Cancer Subscale (LCS)

Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire

Spots Global Cancer Trial Database for A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial