E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER |
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E.1.1.1 | Medical condition in easily understood language |
PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab in patients with PD-L1−positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR according to modified RECIST |
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E.2.2 | Secondary objectives of the trial |
- To evaluate PFS and DOR according to modified RECIST - To evaluate the efficacy of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR, DOR, PFS, where all response endpoints are determined according to RECIST 1.1 - To evaluate OS - To evaluate PFS in patients who experience a confirmed partial response (PR) or confirmed response CR per modified RECIST at any time on study treatment - To evaluate the safety and tolerability of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC - To characterize the pharmacokinetics of Atezolizumab - To evaluate the incidence and titers of ATAs against Atezolizumab and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC - PD-L1−positive status as determined by an IHC assay performed by a central laboratory - ECOG performance status of 0 or 1 - Measurable disease, as defined by RECIST v1.1 - For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of atezolizumab
Inclusion Criteria Unique to Cohort 1: - No prior chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC Inclusion Criteria Unique to Cohorts 2 and 3 - Disease progression during or following prior platinum-based chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC Inclusion Criteria Unique to Cohort 3 - Diagnosis of brain metastases by brain MRI or contrast-enhanced CT |
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E.4 | Principal exclusion criteria |
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Known CNS disease, including treated brain metastases: Cohorts 1 and 2 - Leptomeningeal disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
investigator overall response rate (ORR) per modified RECIST |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
timepoint for evaluation will be 6 months after approximately 130 patients have been enrolled; |
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E.5.2 | Secondary end point(s) |
ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST v1.1, |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
timepoint for evaluation is same as for primary endpoint, with updated analysis approximately 12 months after the last patient is enrolled in the study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
France |
Italy |
Netherlands |
Spain |
Switzerland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date of the last follow-up visit of the last patient enrolled or when all patients have been enrolled into an extension study.
The Sponsor may decide to terminate the study at any time. If the Sponsor decides to end the study, patients who are still receiving study treatment or who are in survival follow-up may be offered enrollment in an extension study or a non-interventional study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |