A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SKYSCRAPER-02)

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Drug: Etoposide; Drug: Tiragolumab; Drug: Placebo; Drug: Atezolizumab; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04256421

GO41767

2019-003301-97 (EudraCT Number)

Details and patient eligibility

About

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 (</= upper limit of normal [ULN] vs. > 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).

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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490 participants in 2 patient groups

Placebo + Atezolizumab + CE

Active Comparator group

Description:

Participants 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.

Treatment:

Drug: Carboplatin

Drug: Atezolizumab

Drug: Placebo

Drug: Etoposide

Tiragolumab + Atezolizumab + CE

Experimental group

Description:

Participants 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.

Treatment:

Drug: Carboplatin

Drug: Atezolizumab

Drug: Tiragolumab

Drug: Etoposide