Small Cell Lung CarcinomaPhase 3SKYSCRAPER-02CNCT04665856
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 3 study testing Tiragolumab, Atezolizumab and Carboplatin in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche at 16 sites in China.
Trial summary
The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Tiragolumab, Atezolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 16 sitesChina
- Study dates
- 21 Dec 2020to 17 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ES-SCLC
- For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
- Measurable diseases as defined by RECIST v1.1
- Submission of a pre-treatment tumor tissue sample
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- Adequate hematologic and end-organ function
- Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) </= 1.5 x ULN
- Participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- Negative Human Immunodeficiency Virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test
- Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
Who cannot join
- Symptomatic or actively progressing central nervous system (CNS) metastases
- Spinal cord compression
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Uncontrolled or symptomatic hypercalcemia
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
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- Malignancies other than SCLC within 5 years prior to randomization
- Active or history of autoimmune disease or immune deficiencies
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan
- Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV
- Severe chronic or active infection
- Treatment with therapeutic oral or IV antibiotics
- Significant cardiovascular disease
- Major surgical procedure other than for diagnosis
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition
- Administration of a live, attenuated vaccine
- Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies
- Treatment with systemic immunostimulatory agents
- Treatment with systemic immunosuppressive medications
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to any component of the tiragolumab or atezolizumab formulations
- History of allergic reactions to carboplatin or etoposide
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab or for 6 months after the final dose of carboplatin or etoposide.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Cancer Hospital
Beijing, 100142
Beijing Chest Hospital
Beijing, 101149
the First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000
the First Hospital of Jilin University
Changchun, 130021
Fujian Provincial Cancer Hospital
Fuzhou, 350014
Cancer Center of Guangzhou Medical University
Guangzhou, 510000
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006
Shanghai Chest Hospital
Shanghai, 200000
Zhongshan Hospital Fudan University
Shanghai, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200120
Cancer Hospital of Shantou University Medical College
Shantou, 515041
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022
Henan Cancer Hospital
Zhengzhou, 450008
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Tiragolumab, Atezolizumab, Carboplatin, Etoposide, Tiragolumab Matching Placebo
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiragolumabDrug
Also called MTIG7192A
Tiragolumab 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.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
CarboplatinDrug
Carboplatin 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.
EtoposideDrug
Etoposide 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 PlaceboDrug
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tiragolumab + Atezolizumab + Carboplatin and Etoposide | Experimental | Induction 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. Receives: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide |
| Placebo + Atezolizumab + Carboplatin and Etoposide | Placebo comparator | Induction 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 Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide; Drug: Tiragolumab Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first in the PAS. 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). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 millimeters (mm) and unequivocal progression of existing non-target lesions. Kalpan-Meier (K-M) method was used to estimate median PFS.
Measured: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Overall Survival (OS) in the PAS
OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate median OS.
Measured: From randomization to death from any cause (up to approximately 32.3 months)
Secondary outcomes (21)
Investigator-assessed PFS in the FAS
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the FAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
Measured: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
OS in the FAS
OS was defined as the time from randomization to death from any cause in the FAS. K-M method was used to estimate median OS.
Measured: From randomization to death from any cause (up to approximately 32.3 months)
Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS
ORR was defined as the percentage of participants with an objective response (OR), characterized by a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as assessed by the investigator according to RECIST v.1.1 in the PAS. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Measured: Up to approximately 32.3 months
Investigator-assessed Confirmed ORR in the FAS
ORR was defined as the percentage of participants with an OR, characterized by a confirmed CR or PR on two consecutive occasions ≥4 weeks apart, as assessed by the investigator according to RECIST v.1.1 in the FAS. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Measured: Up to approximately 32.3 months
Investigator-assessed Duration of Response (DOR) in the PAS
DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first in the PAS. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
Measured: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed DOR in the FAS
DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first in the FAS. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
Measured: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS
PFS rate at 6 months and 12 months was defined as the percentage of participants who did not experience PD as determined by the investigator according to RECIST v1.1, or death from any cause at Months 6 and 12 in the PAS. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the PAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off.
Measured: At Months 6 and 12
Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS
PFS rate at 6 months and 12 months was defined as the percentage of participants who did not experience PD, as determined by the investigator according to RECIST v1.1 or death from any cause, at Months 6 and 12 in the FAS. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the FAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off.
Measured: At Months 6 and 12
OS Rate at 12 Months and 24 Months in the PAS
OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at the specified timepoints in the PAS. OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate OS rate. Percentages have been rounded off.
Measured: At Months 12 and 24
OS Rates at 12 Months and 24 Months in the FAS
OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at the specified timepoints in the FAS. OS was defined as the time from randomization to death from any cause in the FAS. K-M method was used to estimate OS rate. Percentages have been rounded off.
Measured: At Months 12 and 24
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF) and Global Health Status (GHS), as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Core 30 (EORTC QLQ-C30) in the PAS
TTCD=time from randomization to first confirmed clinically meaningful deterioration (CCMD) in PAS. EORTC QLQ-C30=cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, social), 3 symptom scales (fatigue, nausea, vomiting, pain), GHS/quality-of-life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). PF was scored on 4-point scale: 1=Not at all to 4=Very much. GHS/QoL was scored on 7-point scale: 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score for PF or GHS/QoL scale=high/healthy level of functioning/better health-related quality-of-life (HRQoL). CCMD= ≥ 10-point decrease from baseline in PF or GHS scale score held for at least 2 consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. K-M method was used to estimate median TTCD.
Measured: Up to approximately 32.3 months
TTCD in Participant-reported PF and GHS, as Measured by Respective Scales of EORTC QLQ-C30 in the FAS
TTCD was defined as time from randomization to first CCMD in FAS. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, social), 3 symptom scales (fatigue, nausea, vomiting, pain), GHS/QoL, \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). PF was scored on 4-point scale: 1=Not at all to 4=Very much. GHS/QoL was scored on 7-point scale: 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score for PF or GHS/QoL scale=high/healthy level of functioning/better HRQoL. CCMD was defined as ≥ 10-point decrease from baseline in PF or GHS scale score held for at least 2 consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. K-M method was used to estimate median TTCD.
Measured: Up to approximately 32.3 months
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 1 participant randomized to the tiragolumab arm did not receive any dose of tiragolumab and was moved to the placebo arm for safety analysis.
Measured: Up to approximately 57 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
CRS was defined as supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Measured: Up to approximately 57 months
Serum Concentration of Tiragolumab at Specified Timepoints
Measured: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-end of infusion (EOI) on Day 1 of Cycle 1; Treatment discontinuation visit(TDV) (up to approximately 32.3 months) (1 Cycle=21 days)
Serum Concentration of Atezolizumab at Specified Timepoints
Measured: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-EOI on Day 1 of Cycle 1; TDV (up to approximately 32.3 months) (1 Cycle=21 days)
Maximum Plasma Concentration (Cmax) of Tiragolumab
Only sparse pharmacokinetic samples were collected in this study. With the focus on only Cmax and Cmin, there are no additional PK timepoints not reported.
Measured: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle=21 days)
Minimum Plasma Concentration (Cmin) of Tiragolumab
Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Cmax of Atezolizumab
Measured: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle= 21 days)
Cmin of Atezolizumab
Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Number of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Measured: Up to approximately 32.3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start21 Dec 2020
- Primary completion31 Aug 2023
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665856
- Sponsor's protocol ID
- YO42373
- Acronym
- SKYSCRAPER-02C
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2020
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04665856
- Acronym / sponsor ID
- SKYSCRAPER-02C / YO42373
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiragolumab + Atezolizumab + Carboplatin and Etoposide | Experimental | Drug: Tiragolumab, Drug: Atezolizumab, Drug: Carboplatin, Drug: EtoposideInduction 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 Etoposide | Placebo comparator | Drug: Atezolizumab, Drug: Carboplatin, Drug: Etoposide, Drug: Tiragolumab Matching PlaceboInduction 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 ES-SCLC
- For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
- Measurable diseases as defined by RECIST v1.1
Key exclusion criteria (24 listed)
- Symptomatic or actively progressing central nervous system (CNS) metastases
- Spinal cord compression
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Uncontrolled or symptomatic hypercalcemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiragolumabAlso: MTIG7192ATiragolumab 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. | Drug | Tiragolumab + Atezolizumab + Carboplatin and Etoposide |
| AtezolizumabAlso: TecentriqAtezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. | Drug | Placebo + Atezolizumab + Carboplatin and Etoposide, Tiragolumab + Atezolizumab + Carboplatin and Etoposide |
| CarboplatinCarboplatin 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. | Drug | Placebo + Atezolizumab + Carboplatin and Etoposide, Tiragolumab + Atezolizumab + Carboplatin and Etoposide |
| EtoposideEtoposide 100 mg/m^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles. | Drug | Placebo + Atezolizumab + Carboplatin and Etoposide, Tiragolumab + Atezolizumab + Carboplatin and Etoposide |
| Tiragolumab Matching PlaceboMatching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. | Drug | Placebo + Atezolizumab + Carboplatin and Etoposide |
Primary outcome
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)
Time frame: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first in the PAS. 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). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 millimeters (mm) and unequivocal progression of existing non-target lesions. Kalpan-Meier (K-M) method was used to estimate median PFS.
Overall Survival (OS) in the PAS
Time frame: From randomization to death from any cause (up to approximately 32.3 months)
OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate median OS.
21 secondary outcomes
Investigator-assessed PFS in the FAS
Time frame: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
OS in the FAS
Time frame: From randomization to death from any cause (up to approximately 32.3 months)
Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS
Time frame: Up to approximately 32.3 months
Investigator-assessed Confirmed ORR in the FAS
Time frame: Up to approximately 32.3 months
Investigator-assessed Duration of Response (DOR) in the PAS
Time frame: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed DOR in the FAS
Time frame: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS
Time frame: At Months 6 and 12
Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS
Time frame: At Months 6 and 12
OS Rate at 12 Months and 24 Months in the PAS
Time frame: At Months 12 and 24
OS Rates at 12 Months and 24 Months in the FAS
Time frame: At Months 12 and 24
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF) and Global Health Status (GHS), as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Core 30 (EORTC QLQ-C30) in the PAS
Time frame: Up to approximately 32.3 months
TTCD in Participant-reported PF and GHS, as Measured by Respective Scales of EORTC QLQ-C30 in the FAS
Time frame: Up to approximately 32.3 months
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 57 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
Time frame: Up to approximately 57 months
Serum Concentration of Tiragolumab at Specified Timepoints
Time frame: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-end of infusion (EOI) on Day 1 of Cycle 1; Treatment discontinuation visit(TDV) (up to approximately 32.3 months) (1 Cycle=21 days)
Serum Concentration of Atezolizumab at Specified Timepoints
Time frame: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-EOI on Day 1 of Cycle 1; TDV (up to approximately 32.3 months) (1 Cycle=21 days)
Maximum Plasma Concentration (Cmax) of Tiragolumab
Time frame: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle=21 days)
Minimum Plasma Concentration (Cmin) of Tiragolumab
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Cmax of Atezolizumab
Time frame: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle= 21 days)
Cmin of Atezolizumab
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Number of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time frame: Up to approximately 32.3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiragolumab, Atezolizumab and Carboplatin in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) (time frame: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.