Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Nov 2015 → ongoing

Decision date (initial)

2024-05-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-505981-26-00

EudraCT number

2014-003205-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Others

To evaluate the efficacy of atezolizumab monotherapy treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator in the PD-L1 subpopulation (defined as ≥1% TC expression by SP263 IHC assay) within the Stage II-IIIA population, in all randomized patients Stage II–IIIA NSCLC, and in the ITT population

Secondary objectives 1

1. To evaluate the efficacy of atezolizumab monotherapy treatment compared with BSC as measured by overall survival (OS) in ITT population; 3-year and 5-year DFS rates in the PD-L1 subpopulation within the Stage II-IIIA population, in all-randomized patients with Stage II-IIIA NSCLC, and in the ITT population and by DFS in the PD-L1 subpopulation (defined as ≥50% TC expression by the SP263 IHC assay) in patients with Stage II-IIIA subpopulation NSCLC

Conditions and MedDRA coding

Non−Small Cell Lung Cancer

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
3. Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery
4. If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
5. Eligible to receive a cisplatin-based chemotherapy regimen
6. Adequate hematologic and end-organ function

Exclusion criteria 6

1. Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
2. Pregnant and lactating women
3. Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
4. Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
5. Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
6. Participants with hearing impairment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First recurrence of NSCLC, as determined by the investigator after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status Occurrence of new primary NSCLC, as assessed by the investigator Death from any cause

Secondary endpoints 3

1. 1. OS, defined as the time from randomization to death from any cause in the ITT population
2. 2. DFS rates at 3 years and 5 years in the PD-L1-subpopulation and in the Stage II-IIIA population and in the ITT population
3. 3. DFS in the PD-L1-subpopulation within patients with Stage II-IIIA NSCLC

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 12

Locations

9 EU/EEA countries · 69 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications