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Tiragolumab

Phase 3

Esophageal Squamous Cell Carcinoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Jul 23, 2026

Target and mechanism

Molecular targetTIGIT
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment760

FDA Designations

No designations recorded

Clinical trial landscape

Tiragolumab · 7 trials · 7 indications

Phase 3 3Phase 2 3Phase 1 1
NCT04665856Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung CancerSmall Cell Lung Carcinoma
ACTIVE NOT_RECRUITING123 Analytics
NCT04543617A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent ChemoradiotherapyEsophageal Squamous Cell Carcinoma
ACTIVE NOT_RECRUITING760 Analytics
NCT04256421A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung CancerSmall Cell Lung Cancer
COMPLETED490 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Small Cell Lung CarcinomaUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
Esophageal Squamous Cell CarcinomaUnlock trial analytics
PHASE3COMPLETED
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)
Up to 32.3 months

PFS was defined as time from randomization to the first occurrence of disease progression (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).

Overall Survival (OS) in the PAS
Up to 32.3 months

OS was defined as the time from the date of randomization to the date of death from any cause.

Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Arm A vs Arm C: Overall Survival (OS)
From randomization to death from any cause (up to approximately 6 years)
Arm B vs Arm C: OS
From randomization to death from any cause (up to approximately 6 years)
PFS-12
Assessed at 12 weeks

Progression-free survival rate as measured by the proportion of patients free of progression after 12-weeks of treatment

Incidence of adverse events
Assessed until 90 days after the last dose of study treatment or until initiation of new anti-cancer therapy, whichever occurs first

Number of patients with adverse events as measured according to CTCAE v5.0

Progression-free Survival (PFS) as Determined by the Investigator
From randomization to first occurrence of PD or death from any cause (up to approximately 40 months)

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS.

Overall Survival (OS)
From randomization to death from any cause (up to approximately 40 months)

OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.

Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
From randomization up to approximately 17 months

ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off.

Percentage of Participants With Adverse Events (Cohort B)
Up to approximately 21 months
Confirmed Objective Response Rate ORR (Cohort A)
Up to approximately 21 months

Secondary Endpoints

PFS in the FAS
Up to 32.3 months
OS in the FAS
Up to 32.3 months
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Up to 32.3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tiragolumab + Atezolizumab + Carboplatin and EtoposideEXPERIMENTALInduction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.
Placebo + Atezolizumab + Carboplatin and EtoposidePLACEBO_COMPARATORInduction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles
Arm A: Tiragolumab + AtezolizumabEXPERIMENTALParticipants will receive atezolizumab followed by tiragolumab.
Arm B: Tiragolumab Placebo + AtezolizumabEXPERIMENTALParticipants will receive atezolizumab followed by tiragolumab matching placebo.
Arm C: Tiragolumab Placebo + Atezolizumab PlaceboPLACEBO_COMPARATORParticipants will receive matching placebos to tiragolumab and atezolizumab.
Placebo + Atezolizumab + CEACTIVE_COMPARATORParticipants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
Tiragolumab + Atezolizumab + CEEXPERIMENTALParticipants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
Tiragolumab and atezolizumabEXPERIMENTALTiragolumab 600mg and atezolizumab 1200 mg, both every three weeks
Tiragolumab and ipilimumabEXPERIMENTALTiragolumab 600mg every 3 weeks and ipilimumab 1mg/kg every 3 weeks for the first 4 cycles
Tiragolumab, atezolizumab and ipilimumabEXPERIMENTALTiragolumab 600mg and atezolizumab 1200mg both every 3 weeks, plus ipilimumab 1mg/kg every 3 weeks for the first 4 cycles
Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or CisplatinEXPERIMENTALInduction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
Placebo+Pembrolizumab+Pemetrexed+Carboplatin or CisplatinPLACEBO_COMPARATORInduction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.
Tiragolumab plus AtezolizumabEXPERIMENTALParticipants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
AtezolizumabEXPERIMENTALParticipants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxelEXPERIMENTALParticipants with first-line metastatic TNBC will receive tiragolumab and atezolizumab on Day 1 of every 28-day cycle plus nab-paclitaxel on Days 1, 8, and 15 of every 28-day cycle.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-ACEXPERIMENTALParticipants with early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab every 2 weeks (Q2W) in combination with nab-paclitaxel weekly (QW) and carboplatin every 3 weeks (Q3W) for four cycles, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for four doses.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-ACEXPERIMENTALParticipantswith early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab Q2W in combination with nab-paclitaxel QW for 12 weeks, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with G-CSF (filgrastim or pegfilgrastim) or GM-CSF support for four doses.

Interventions

NameTypeDescription
TiragolumabDRUGTiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
AtezolizumabDRUGAtezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
CarboplatinDRUGCarboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
EtoposideDRUGEtoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
Tiragolumab Matching PlaceboDRUGMatching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Atezolizumab Matching PlaceboDRUGAtezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
PlaceboDRUGPlacebo administered by IV infusion on Day 1 of each 21-day cycle.
IpilimumabDRUG1 mg/kg, maximum of 4 cycles
PemetrexedDRUGPemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
CisplatinDRUGCisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
PembrolizumabDRUGPembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
Nab-paclitaxelDRUGNab-paclitaxel 100 milligrams per square meter (mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
DoxorubicinDRUGDoxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
CyclophosphamideDRUGCyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
Granulocyte colony-stimulating factor (G-CSF)DRUGG-CSF support for four doses.
Granulocyte-macrophage colony-stimulating factor (GM-CSF)DRUGGM-CSF support for four doses.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system * No prior systemic treatment for...

Countries:ChinaUnited StatesArgentinaAustraliaAustriaBelgiumFranceGermanyGreeceHungaryIsraelItalyJapanKenyaMoroccoNew ZealandPolandPortugalRussiaSouth AfricaSouth KoreaSpainSwitzerlandTaiwanThailandTurkey (Türkiye)UkraineUnited KingdomBrazilCzechiaNetherlandsSerbiaSingaporeCanadaDenmarkHong KongMexicoCosta RicaPanamaPeru
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Frequently asked questions about Tiragolumab

What is Tiragolumab used for?

Tiragolumab is an investigational antibody being studied in oncology for several cancers, including esophageal squamous cell carcinoma, small cell lung carcinoma, metastatic breast cancer, triple-negative breast cancer, PD-L1-selected solid tumors, and non-small cell lung cancer (NSCLC). It is in Phase 2 clinical development for these indications.

What does Tiragolumab target?

Tiragolumab is a monoclonal antibody (a -mab class drug) that targets a pathway involved in cancer immunity. It is being studied in combination with other therapies, such as atezolizumab, in clinical trials for various solid tumors.

Who makes Tiragolumab?

Tiragolumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple cancer types.

What phase is Tiragolumab in?

Tiragolumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its use in various oncology indications.

What clinical trials is Tiragolumab in?

Tiragolumab has been studied in several trials, including NCT04300647, a Phase 2 study in cervical cancer; NCT04665856, a Phase 3 study in small cell lung cancer; NCT05661578, a Phase 2 study in solid tumors; and NCT06342037, a Phase 2 study in triple-negative breast cancer.

Is Tiragolumab the same as atezolizumab?

No, Tiragolumab is not the same as atezolizumab. Tiragolumab is a separate investigational antibody that is often studied in combination with atezolizumab, as seen in trials like NCT04300647 and NCT04665856, where the two drugs are given together.