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A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Atezolizumab

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene will be excluded from this study. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible.
The last dose of prior systemic anticancer therapy must have been administered ≥ 21 days prior to the first study treatment.
The last dose of prior anti-PD-1 therapy must have been administered
Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
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 or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy

Exclusion Criteria:

Patients with EGFR mutation or ALK fusion oncogene
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 the first study treatment
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
Significant cardiovascular disease
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
Prior allogeneic stem cell or solid organ transplantation

Sites / Locations

Peking Union Medical College Hospital
Sichuan Cancer Hospital
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
Taizhou Hospital of Zhejiang Province
Fudan University Shanghai Cancer Center; Medical Oncology
Cancer Hospital Affliated to Xinjiang Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atezolizumab

Arm Description

Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Outcomes

Primary Outcome Measures

Serious Adverse Event Incidence Rates

The incidence of serious adverse events (SAEs) related to atezolizumab.

Secondary Outcome Measures

Overall Survival (OS) Rate

Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment

Overall survival (OS), defined as the time from initiation of study treatment to death from any cause

Progression-Free Survival (PFS)

Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.

Objective Response Rate (ORR)

Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST

Duration of Response (DOR)

Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study.

EQ-5D-5L Index-Based and VAS scores

EQ-5D-5L, EuroQol 5-Dimension Questionnaire is a self-report health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The EuroQol EQ-5D 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 analog scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.

EORTC QLQ-LC13 score

EORTC QLQ-LC13, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module will be used to assess self-reported outcomes. EORTC QLQ-LC13 includes 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.

Full Information

NCT ID

NCT03922997

First Posted

April 18, 2019

Last Updated

September 8, 2022

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03922997

Brief Title

A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Official Title

An Open-Label, Singe Arm, Multicenter Study to Investigate the Safety and Efficacy of Atezolizumab (Tecentriq) in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

July 3, 2019 (Actual)

Primary Completion Date

August 11, 2022 (Actual)

Study Completion Date

August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atezolizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Other Intervention Name(s)

Tecentriq

Intervention Description

Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.

Primary Outcome Measure Information:

Title

Serious Adverse Event Incidence Rates

Description

The incidence of serious adverse events (SAEs) related to atezolizumab.

Time Frame

Baseline up to approximately 3 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS) Rate

Description

Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment

Time Frame

Baseline to 2 years

Title

Description

Overall survival (OS), defined as the time from initiation of study treatment to death from any cause

Time Frame

Baseline up to approximately 3 years

Title

Progression-Free Survival (PFS)

Description

Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.

Time Frame

Baseline up to approximately 3 years

Title

Objective Response Rate (ORR)

Description

Time Frame

Baseline up to approximately 3 years

Title

Duration of Response (DOR)

Description

Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study.

Time Frame

Baseline up to approximately 3 years

Title

EQ-5D-5L Index-Based and VAS scores

Description

Time Frame

Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years)

Title

EORTC QLQ-LC13 score

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene will be excluded from this study. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible. The last dose of prior systemic anticancer therapy must have been administered ≥ 21 days prior to the first study treatment. The last dose of prior anti-PD-1 therapy must have been administered Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1) Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible 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 or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy Exclusion Criteria: Patients with EGFR mutation or ALK fusion oncogene 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 the first study treatment 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 Significant cardiovascular disease 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 Prior allogeneic stem cell or solid organ transplantation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing City

ZIP/Postal Code

100032

Country

China

Facility Name

Sichuan Cancer Hospital

City

Chengdu City

ZIP/Postal Code

610041

Country

China

Facility Name

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

City

Hangzhou City

ZIP/Postal Code

310022

Country

China

Facility Name

Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy

City

Harbin

ZIP/Postal Code

150049

Country

China

Facility Name

Taizhou Hospital of Zhejiang Province

City

Linhai

ZIP/Postal Code

317000

Country

China

Facility Name

Fudan University Shanghai Cancer Center; Medical Oncology

City

Shanghai City

ZIP/Postal Code

201315

Country

China

Facility Name

Cancer Hospital Affliated to Xinjiang Medical University

City

Urumqi City

ZIP/Postal Code

830011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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