A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
New lung cancer treatment tested in phase 3 trial
Plain English Summary
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Small Cell Lung Cancer. This trial tests a new combination of drugs, including tiragolumab, atezolizumab, carboplatin, and etoposide, to see if it's more effective than standard treatment for extensive-stage small cell lung cancer. It is for patients with untreated extensive-stage small cell lung cancer who have a good performance status. Participants will receive one of two treatment regimens, assigned randomly, and will be monitored for side effects and treatment response. Standard chemotherapy is the current alternative treatment for this condition. The trial aims to enroll 490 participants.
Official 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 (\</= 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with newly diagnosed extensive-stage small cell lung cancer can join. You must not have received prior treatment for extensive-stage small cell lung cancer. Patients must have a good general health status (ECOG performance status of 0 or 1). Patients with active or progressing brain metastases cannot participate. This trial is studying Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The trial will measure how long patients live and how long they live without their cancer getting worse, which indicates how well the new treatment controls the disease. The specific primary outcome measures are: Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) (From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months)); Overall Survival (OS) in the PAS (From randomization to death from any cause (up to approximately 24 months)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to find a more effective treatment for extensive-stage small cell lung cancer, addressing a significant unmet need in a difficult-to-treat cancer. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial investigates a novel immunotherapy combination for a common lung cancer subtype, potentially offering a new standard of care and representing a significant market opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for your specific situation and if you meet all the requirements. Participation involves regular clinic visits for treatment infusions, blood tests, scans, and check-ups to monitor your health and the cancer's response. You will be randomly assigned to receive either the new drug combination or a placebo with standard treatment. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 490 participants
Interventions
- DRUG: Tiragolumab — Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
- DRUG: Atezolizumab — Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
- DRUG: Carboplatin — Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
- DRUG: Etoposide — Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
- DRUG: Placebo — Placebo administered by IV infusion on Day 1 of each 21-day cycle.
Primary Outcomes
- Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) (From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months))
- Overall Survival (OS) in the PAS (From randomization to death from any cause (up to approximately 24 months))
Secondary Outcomes
- PFS in the FAS (From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months))
- OS in the FAS (From randomization to death from any cause (up to approximately 24 months))
- Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS (From randomization up to approximately 24 months)
- Investigator-assessed Confirmed ORR in the FAS (From randomization up to approximately 24 months)
- Investigator-assessed Duration of Response (DOR) in the PAS (From the first occurrence of a documented confirmed objective response (OR) to PD or death from any cause, whichever occurred first (up to approximately 24 months))
Full 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
Trial Locations
- Rocky Mountain Cancer Centers - Lone Tree, Lone Tree, Colorado, United States
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington D.C., District of Columbia, United States
- Florida Cancer Specialists, Fort Myers, Florida, United States
- SCRI Florida Cancer Specialists North, Sarasota, Florida, United States
- Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States
- Illinois Cancer Care, Peoria, Illinois, United States
- New England Cancer Specialists, Scarborough, Maine, United States
- Weinberg Cancer Institution at Franklin Square, Baltimore, Maryland, United States
- Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
- Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT04256421?
NCT04256421 is a Phase 3 INTERVENTIONAL study titled "A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer." It is currently completed and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 490 participants.
What conditions does NCT04256421 study?
This trial investigates treatments for Small Cell Lung Cancer. The primary condition under study is Small Cell Lung Cancer.
What treatments are being tested in NCT04256421?
The interventions being studied include: Tiragolumab (DRUG), Atezolizumab (DRUG), Carboplatin (DRUG), Etoposide (DRUG), Placebo (DRUG). Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
What does Phase 3 mean for NCT04256421?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT04256421?
This trial is currently "Completed." It started on 2020-02-04. The estimated completion date is 2025-07-31.
Who is sponsoring NCT04256421?
NCT04256421 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04256421?
The trial aims to enroll 490 participants. The trial status is completed.
How is NCT04256421 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04256421?
The primary outcome measures are: Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) (From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months)); Overall Survival (OS) in the PAS (From randomization to death from any cause (up to approximately 24 months)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04256421 being conducted?
This trial is being conducted at 20 sites, including Lone Tree, Colorado; Washington D.C., District of Columbia; Fort Myers, Florida; Sarasota, Florida and 16 more sites (United States, Australia).
Where can I find official information about NCT04256421?
The official record for NCT04256421 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04256421. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04256421 testing in simple terms?
This trial tests a new combination of drugs, including tiragolumab, atezolizumab, carboplatin, and etoposide, to see if it's more effective than standard treatment for extensive-stage small cell lung cancer. It is for patients with untreated extensive-stage small cell lung cancer who have a good performance status.
Why is this trial significant?
This trial aims to find a more effective treatment for extensive-stage small cell lung cancer, addressing a significant unmet need in a difficult-to-treat cancer. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT04256421?
Common side effects may include fatigue, nausea, vomiting, diarrhea, and skin rash. More serious risks can include immune-related side effects affecting organs like the lungs, liver, or thyroid, and infusion-related reactions. The new drug tiragolumab is an immunotherapy that can sometimes cause the body's immune system to attack healthy tissues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04256421?
Ask your doctor if this trial is a good fit for your specific situation and if you meet all the requirements. Participation involves regular clinic visits for treatment infusions, blood tests, scans, and check-ups to monitor your health and the cancer's response. You will be randomly assigned to receive either the new drug combination or a placebo with standard treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04256421 signal from an investment perspective?
This trial investigates a novel immunotherapy combination for a common lung cancer subtype, potentially offering a new standard of care and representing a significant market opportunity. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive one of two treatment regimens, assigned randomly, and will be monitored for side effects and treatment response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Small Cell Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.