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)

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,472

Study arms

• Experimental
  Atezolizumab

  Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).

  Drug: Atezolizumab

Interventions

• DrugAtezolizumab

  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).

  Also known as: RO5541267, Tecentriq

Primary outcomes

1. Percentage of Participants With Adverse Events

   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.

   Time frame: Baseline up to 4 years

Secondary outcomes

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

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

   Time frame: Baseline up to Year 2

2. Overall Survival (OS)

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

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

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)

   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.

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

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

   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'.

   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)

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

   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'.

   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)

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

   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'.

   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)

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

   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'.

   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)

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

   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'.

   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)

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

   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.

   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)

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

    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.

    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)

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

    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.

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

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

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

    Time frame: Baseline up to Year 3

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

    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.

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

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

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

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

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

    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.

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

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

    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.

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

Baseline characteristics

Publications

• Ardizzoni A, Azevedo S, Rubio-Viqueira B, Rodriguez-Abreu D, Alatorre-Alexander J, Smit HJM, Yu J, Syrigos K, Trunzer K, Patel H, Tolson J, Cardona A, Perez-Moreno PD, Newsom-Davis T. Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer. J Immunother Cancer. 2021 Mar;9(3):e001865. doi: 10.1136/jitc-2020-001865. PubMed 33737339 ↗

Study documents

• Study protocol · Mar 23, 2021
• Statistical analysis plan · Jul 17, 2019

Documents are hosted by the registry — open the source record to download them.