Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
135
Countries
2
Sites
11
Non-small cell lung cancer (NSCLC)
To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by objective response rate (ORR) and progression-free survival (PFS)
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Jul 2018 → 14 Nov 2025
- Decision date (initial)
- 2024-05-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Genentech Inc.
External identifiers
- EU CT number
- 2023-508083-30-00
- EudraCT number
- 2018-000280-81
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic, Others
To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by objective response rate (ORR) and progression-free survival (PFS)
Secondary objectives 4
- 1. To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, as measured by duration of objective response (DOR) and overall survival (OS)
- 2. To evaluate the safety and tolerability of tiragolumab plus atezolizumab compared with placebo plus atezolizumab
- 3. To characterize the pharmacokinetic (PK) profile of tiragolumab and atezolizumab
- 4. To evaluate the immune response to tiragolumab and atezolizumab
Conditions and MedDRA coding
Non-small cell lung cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Eligible patients will be randomized 1:1 to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
|
Randomised Controlled | Double | [{"id":112766,"code":1,"name":"Subject"},{"id":112767,"code":2,"name":"Investigator"}] | Control arm: Placebo + Atezolizumab: Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. Experimental arm: Tiragolumab + Atezolizumab: Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
| 2 | Follow-up After study treatment discontinuation, patients will be followed for survival status and subsequent anti-cancer therapies, approximately every 3 months until death, loss to follow-up, withdrawal of consent, or study termination by the Sponsor, whichever occurs first.
|
Randomised Controlled | Double | [{"id":112770,"code":2,"name":"Investigator"},{"id":112769,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
- Tumor PD-L1 expression on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Confirmed availability of representative tumor specimens, along with an associated pathology report
- Measurable disease as defined by RECIST v1.1
- Life expectancy ≥12 weeks
- Adequate hematologic and end-organ function
Exclusion criteria 6
- Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- Symptomatic, untreated, or actively progressing CNS metastases
- Spinal cord compression not definitively treated with surgery and/or radiation
- History of leptomeningeal disease
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. ORR as determined by the investigator according to RECIST v1.1
- 2. PFS as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Secondary endpoints 6
- 1. DOR as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
- 2. Overall survival
- 3. Incidence, nature, and severity of adverse events, graded according to the NCI CTCAE v4.0
- 4. Clinically significant changes from baseline in vital signs, physical findings, and clinical laboratory results
- 5. Serum concentrations of tiragolumab or atezolizumab at specified timepoints
- 6. Incidence of treatment-emergent Anti-drug antibodies (ADAs) and their potential impact on safety, efficacy, and pharmacokinetics
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD7846761 · Product
- Active substance
- Tiragolumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 62.4 g gram(s)
- Max treatment duration
- 312 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 124.8 g gram(s)
- Max treatment duration
- 312 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| DHL Supply Chain Operations GmbH ORG-100040715
|
Florstadt, Germany | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other |
| European Organisation For Research And Treatment Of Cancer ORG-100010848
|
Sint-Lambrechts-Woluwe, Belgium | Other |
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 2 |
| Spain | Ended | 35 | 9 |
| Rest of world
Serbia, United States, Korea, Republic of, Taiwan
|
— | 88 | — |
Investigational sites
Centr Georges Francois Leclerc
Service d'Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Regional De Marseille
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Quironsalud Sagrado Corazon
Oncology, Calle De Rafael Salgado 3, 41013, Sevilla
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2018-09-04 | 2025-03-20 | 2018-10-08 | 2019-03-20 | |
| Spain | 2018-07-19 | 2025-07-08 | 2018-07-31 | 2019-03-20 |
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
| Title | Submission date | Status | Type |
|---|---|---|---|
| GO40290_final results summary SUM-128841
|
2026-04-14T11:10:34 | Submitted | Summary of Results |
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508083-30-00 Redacted | 7 |
| Protocol (for publication) | d4_patient facing documents_qlqc30_es | 3 |
| Recruitment arrangements (for publication) | K1_Genentech_GO40290_Recruitment Arrangement_France_Placeholder_Public | n/a |
| Recruitment arrangements (for publication) | K1_GO40290_Recruitment-Arrangement_NtF_ES_Public | n/a |
| Subject information and informed consent form (for publication) | L1_GO40290_Genomic_ICF_FRA_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Main ICF_FRA_French_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Main-ICF_ES_Spanish_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Optional-Biopsies-ICF_ES_Spanish_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Optional-Collection-of-leftover_ICF_ES_Spanish_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Optional-collection-stool-ICF_ES_Spanish_Public | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Optional-Treat-continuation-ICF_ES_Spanish_Public | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Pregnant Partner_ICF_FRA_French_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GO40290_Pregnant-Partn-Author-ICF_ES_Spanish_Public | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_GO40290_Prescreening_ICF_FRA_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_GO40290_Prescreening-ICF_ES_Spanish_Public | 1.2.0 |
| Summary of results (for publication) | GO40290_EU CTIS Final Results | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-508083-30-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-508083-30-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2023-508083-30-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-27 | Spain | Acceptable 2024-05-06
|
2024-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-20 | Spain | Acceptable 2025-05-23
|
2025-05-23 |