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Completed

NCT Number: NCT03285763

A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Aleman, Caba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy, after anti-PD-1 as monotherapy, or after TKI therapy). Participants with a previously detected sensitizing epidermal growth factor receptor (EGFR) mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion oncogene must have received targeted therapy (TKI) followed by at least one line of standard systemic chemotherapy prior to receiving atezolizumab. Overall, participants should not have received more than two lines of standard systemic chemotherapy. Participants who have discontinued first-line or second-line therapy due to intolerance are also eligible
  • The last dose of prior systemic anticancer therapy or targeted therapy must have been administered more than or equal to (≥) 21 days prior to randomization.
  • The last dose of prior anti-PD-1 therapy must have been administered. Nivolumab must have been discontinued >= 14 days and pembrolizumab >= 21 days prior to study treatment initiation, providing that these treatments were not administered in a clinical trial setting.
  • Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
  • Participants with asymptomatic central nervous system (CNS) metastases (treated or untreated), as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic evaluation, are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Life expectancy ≥ 12 weeks
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab
  • Participants must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy

Exclusion criteria

  • Symptomatic CNS metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to study treatment initiation
  • Leptomeningeal disease
  • Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
  • Pregnant or lactating, or intending to become pregnant during the study
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
  • Significant renal disorder requiring dialysis or indication for renal transplant
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
  • Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
  • Inability to understand the local language(s) for which the EORTC QLQ-LC13 and EQ-5D-5L questionnaires are available
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
  • Active tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies other than anti-PD-1 therapy, including anti-programmed death-ligand 1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
  • Specifically for participants without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial. For participants with CNS metastases, use of prednisone at a stable dose (or dose equivalent) of <= 20 mg/day is acceptable.

Treatment and study plan

Atezolizumab

Drug

Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).

Other names: RO5541267, Tecentriq

Primary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Baseline up to 4 years

    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.

Secondary outcomes

  1. Percentage of Participants Alive 2 Years After Initiation of Treatment

    Time frame: Baseline up to Year 2

    The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment.

  2. Overall Survival (OS)

    Time frame: Baseline up to death (up to 4 years)

    OS was defined as the time (in months) from initiation of study treatment to death from any cause.

  3. Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)

    Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)

    PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1.

  4. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

  5. EQ-5D-5L Questionnaire - Self-Care Item

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

  6. EQ-5D-5L Questionnaire - Usual Activities Item

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

  7. EQ-5D-5L Questionnaire - Pain/Discomfort Item

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

  8. EQ-5D-5L Questionnaire - Anxiety/Depression Item

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

  9. EQ-5D-5L Questionnaire - VAS Scores

    Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline.

  10. European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)

    Time frame: Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)

    The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A >=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline.

  11. Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST

    Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)

    PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST.

  12. Percentage of Participants Alive 3 Years After Initiation of Treatment

    Time frame: Baseline up to Year 3

    The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment.

  13. Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1

    Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)

    Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1.

  14. Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST

    Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)

    The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST.

  15. Duration of Response as Assessed by the Investigator According to RECIST v.1.1

    Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

    DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR.

  16. Duration of Response as Assessed by the Investigator According to Modified RECIST

    Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)

    DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)

Acronym: TAIL

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2017
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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