E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE |
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E.1.1.1 | Medical condition in easily understood language |
NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029514 |
E.1.2 | Term | Non-small cell lung cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 objective of this study is to determine if Atezolizumab treatment results in superior OS compared with docetaxel treatment in patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen
|
|
E.2.2 | Secondary objectives of the trial |
The secondary efficacy objectives of this study are:
- To evaluate efficacy of atezolizumab compared with docetaxel with respect to anti-tumor effects as measured by PFS per investigator using RECIST v1.1
- To evaluate efficacy of atezolizumab compared with docetaxel with
respect to anti-tumor effects as measured by DOR per RECIST v1.1 for
responding patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
•Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment
•Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
•Measurable disease, as defined by RECIST v1.1
•ECOG performance status of 0 or 1
•Life expectancy > 12 weeks
• 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 |
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E.4 | Principal exclusion criteria |
•Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization
•Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
•Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
•Positive test for HIV
•Untreated or symptomatic central nervous system metastases
•History of autoimmune disease |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint for this trial is duration (in months) of OS
(overall survival). OS duration is defined as the difference in time from
the date of randomization to the date of death due to any cause. Data for
patients who are not reported as having died at the time of analysis will
be censored at the date they were last known to be alive. Patients who
do not have post-baseline information will be censored at the date of
randomization plus 1 day.
The OS analyses will be performed for the PP (Primary Population) at the
PAT (Primary Analysis Time) and for the SP (Secondary Population) at
the SAT (Secondary Analysis Time). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time from the date of randomization to the date of death due to any cause |
|
E.5.2 | Secondary end point(s) |
PFS is defined as the time (in months) between the date of
randomization and the date of first documented disease progression or
death, whichever occurs first. Disease progression will be determined
based on investigator assessment using RECIST v1.1. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 93 |
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 |
Brazil |
Canada |
Chile |
Guatemala |
Japan |
Korea, Republic of |
Mexico |
New Zealand |
Panama |
Russian Federation |
Serbia |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
Austria |
Finland |
France |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Norway |
Poland |
Portugal |
Spain |
Sweden |
Switzerland |
United Kingdom |
Argentina |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
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 are in survival follow-up may be offered enrollment in an
extension study or a non-interventional study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 5 |