Phase 3
Completed N=490
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT04256421 ↗Enrolled (actual)
490
Serious AEs
44.7%
Results posted
Oct 2025
Primary outcomePrimary: Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) — 5.55; 5.36 months — p=0.3504
◆ Published Evidence
Highly cited
110citations · ~55 / year
SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer.
Summary
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH ( ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:
* Arm A: Tiragolumab plus atezolizumab plus CE
* Arm B: Placebo plus atezolizumab plus CE
Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Linked Publications
-
SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) |
5.55; 5.36 | 0.3504 |
| PRIMARY Overall Survival (OS) in the PAS |
13.14; 13.11 | 0.2859 |
| SECONDARY PFS in the FAS |
5.42; 5.06 | 0.4440 |
| SECONDARY OS in the FAS |
12.91; 12.75 | 0.4205 |
| SECONDARY Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS |
66.7; 73.5 | 0.1418 |
| SECONDARY Investigator-assessed Confirmed ORR in the FAS |
65.6; 70.8 | 0.2191 |
| SECONDARY Investigator-assessed Duration of Response (DOR) in the PAS |
5.59; 4.19 | — |
| SECONDARY Investigator-assessed DOR in the FAS |
5.11; 4.17 | — |
| SECONDARY Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS |
42.42; 35.15; 17.29; 14.21 | — |
| SECONDARY Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS |
37.95; 31.30; 14.07; 12.33 | — |
| SECONDARY OS Rates at 12 Months and 24 Months in the PAS |
57.74; 54.00; 27.68; 19.56 | 0.4580 |
| SECONDARY OS Rates at 12 Months and 24 Months in the FAS |
55.84; 52.82; 25.82; 20.53 | 0.5059 |
| SECONDARY Time to Confirmed Deterioration (TTCD) of European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (PF) in the PAS |
19.35; 15.67 | 0.9819 |
| SECONDARY TTCD of EORTC QLQ-C30 Physical Functioning in the FAS |
19.35; 15.67 | 0.5122 |
| SECONDARY TTCD of EORTC QLQ-C30 Global Health Status (GHS)/Quality-of-life (QoL) in the PAS |
NA; NA | 0.3614 |
| SECONDARY TTCD of EORTC QLQ-C30 GHS/QoL in the FAS |
NA; NA | 0.1681 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
245; 238 | — |
| SECONDARY Number of Participants With Severity of Cytokine-release Syndrome (CRS), as Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale |
1; 0 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of Tiragolumab |
29.5; 46.5; 56.3; 76.3; 78.8; 96.4 | — |
| SECONDARY Cmin of Atezolizumab |
75.0; 75.4; 121; 125; 144; 155 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Tiragolumab |
188 | — |
| SECONDARY Cmax of Atezolizumab |
398; 405 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab |
2; 3; 3; 0 | — |
| SECONDARY Number of Participants With ADAs to Atezolizumab |
2; 1; 48; 22; 48; 22 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Exclusion Criteria
- Symptomatic or actively progressing central nervous system (CNS) metastases
- Malignancies other than small cell lung cancer (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
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infection at the time of randomization
- Treatment with any other investigational agent within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
Data sourced from ClinicalTrials.gov (NCT04256421) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.