A Study of Atezolizumab plus Carboplatin and Etoposide with or Without Tiragolumab (Anti-Tigit Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

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

19 Jun 2020 → 1 Aug 2025

Decision date (initial)

2024-09-23

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

2022-502988-37-00

EudraCT number

2019-003301-97

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacokinetic

To evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in patients with untreated extensive-stage small cell lung cancer (ES-SCLC) on the basis of progression free survival (PFS) and overall survival (OS) in primary analysis set (PAS) (patients without presence or history of brain metastases at baseline)

Secondary objectives 5

1. To evaluate the efficacy of tiragolumab plus atezolizumab and CE compared with placebo plus atezolizumab and CE on the basis of PFS in the full analysis set (FAS), OS in the FAS, confirmed objective response rate, duration of response, progression free survival at 6 months and at 12 months, overall survival rates at 12 months and 24 months and time to confirmed deterioration in the PAS and FAS
2. To evaluate the safety of tiragolumab plus atezolizumab and CE compared with placebo plus atezolizumab and CE
3. To characterize the pharmacokinetics of tiragolumab and atezolizumab
4. To evaluate the immune response to tiragolumab and atezolizumab
5. To evaluate the impact of health status utility scores of patients treated with tiragolumab plus atezolizumab and CE compared with placebo plus atezolizumab and CE

Conditions and MedDRA coding

Small cell lung cancer (SCLC)

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Eastern Cooperative Oncology Group performance status of 0 or 1
2. Histologically or cytologically confirmed ES-SCLC
3. No prior systemic treatment for ES-SCLC
4. Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1
5. Adequate hematologic and end-organ function
6. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

Exclusion criteria 6

1. Symptomatic or actively progressing CNS metastases
2. Leptomeningeal disease
3. Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
4. Active or history of autoimmune disease or immune deficiency
5. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
6. Severe infection at the time of randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Progression-free survival in the PAS
2. 2. Overall survival in the PAS

Secondary endpoints 13

1. 1. Progression free survival in the FAS
2. 2. Overall survival in the FAS
3. 3. Confirmed objective response rate in the PAS and FAS population
4. 4. Duration of response in the PAS and FAS population
5. 5. Progression-free survival rates at 6 months and at 12 months in the PAS and FAS population
6. 6. Overall survival rates at 12 months and 24 months in the PAS and FAS population
7. 7. Time to confirmed deterioration in the PAS and FAS population
8. 8. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
9. 9. Severity for cytokine-release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS consensus grading scale
10. 10. Minimum serum concentration [Cmin]of tiragolumab and atezolizumab at specified timepoints
11. 11. Maximum serum concentration [Cmax] of tiragolumab and atezolizumab at specified timepoints
12. 12. Prevalence of ADAs to tiragolumab and atezolizumab at baseline and during the study
13. 13. Change in EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and Visual Analog Scale scores at specified timepoints during the study

Investigational products

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

Test 2

Placebo 1

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 8

Locations

3 EU/EEA countries · 9 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 27 files

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

Application history

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