1069 Participants Needed

Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

(STAR-121 Trial)

Recruiting at 190 trial locations
GC
Overseen ByGilead Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two new drugs, zimberelimab and domvanalimab, combined with chemotherapy for patients with advanced lung cancer that has spread and lacks specific genetic targets. These drugs help the immune system better recognize and attack cancer cells. The goal is to see if this combination improves survival compared to another drug, pembrolizumab, with chemotherapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroids or have an active autoimmune disease requiring treatment, you may not be eligible to participate.

Is the combination of immunotherapy and chemotherapy safe for treating non-small cell lung cancer?

Studies have shown that combinations like pembrolizumab with carboplatin and pemetrexed, as well as carboplatin with nab-paclitaxel, have been used safely in treating advanced non-small cell lung cancer. These treatments are generally considered safe, but as with any medical treatment, they can have side effects, and it's important to discuss these with your doctor.12345

What makes the drug combination of immunotherapy and chemotherapy unique for treating non-small cell lung cancer?

This treatment combines immunotherapy drugs like pembrolizumab and zimberelimab with chemotherapy agents such as carboplatin and nab-paclitaxel, aiming to enhance the immune response against cancer cells while also directly targeting them with chemotherapy. This dual approach is designed to improve outcomes compared to using chemotherapy or immunotherapy alone.36789

What data supports the effectiveness of the drug combination for non-small cell lung cancer?

Research shows that the combination of paclitaxel and carboplatin has been widely used and is effective in treating non-small cell lung cancer, with studies reporting a 1-year survival rate as high as 54%. Additionally, the combination of nanoparticle albumin-bound paclitaxel with carboplatin has shown favorable efficacy and tolerability, especially in elderly patients.47101112

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults with untreated metastatic non-small cell lung cancer without certain genetic mutations. Participants should have a good performance status, no prior treatments targeting immune checkpoints, and no history of severe lung conditions or active autoimmune diseases. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

You are expected to live for at least 3 more months.
My lung cancer is at stage IV.
My organs are working well.
See 5 more

Exclusion Criteria

Known hypersensitivity to the study drug, its metabolites, or formulation excipient
I have not received a live-virus vaccine in the last 30 days.
I have or had lung inflammation that needed steroids.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zimberelimab and Domvanalimab in combination with chemotherapy or Pembrolizumab with chemotherapy every 3 weeks for up to 35 doses

Up to 68 months
Every 3 weeks

Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 68 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cisplatin
  • Domvanalimab
  • Nab-paclitaxel
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed
  • Zimberelimab
Trial Overview The study compares the effectiveness of two immunotherapy drugs (Zimberelimab and Domvanalimab) combined with chemotherapy against Pembrolizumab with chemotherapy in extending life and delaying cancer progression in patients.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Zimberelimab (ZIM) +Domvanalimab (DOM) + ChemotherapyExperimental Treatment7 Interventions
Group II: Zimberelimab (ZIM) + ChemotherapyExperimental Treatment6 Interventions
Group III: Pembrolizumab (PEMBRO) + ChemotherapyActive Control6 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Arcus Biosciences, Inc.

Industry Sponsor

Trials
44
Recruited
7,500+

Published Research Related to This Trial

In a phase III trial involving 1,052 patients with advanced non-small-cell lung cancer, nab-paclitaxel plus carboplatin showed a significantly higher overall response rate (33%) compared to solvent-based paclitaxel plus carboplatin (25%), indicating greater efficacy in treatment.
Nab-paclitaxel was associated with fewer severe side effects, such as neuropathy and neutropenia, compared to solvent-based paclitaxel, suggesting it may be a safer option for patients.
Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial.Socinski, MA., Bondarenko, I., Karaseva, NA., et al.[2022]
The combination of paclitaxel and carboplatin has shown promising results in treating advanced non-small-cell lung cancer (NSCLC), with reported 1-year survival rates as high as 54%, making it a widely used regimen in clinical practice.
This combination therapy has been effective without additional toxicity, allowing for full doses of both drugs to be administered, and is currently being evaluated in ongoing studies for earlier stages of the disease.
Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer.Belani, CP.[2015]
In a phase II trial involving 32 elderly patients with untreated advanced non-small cell lung cancer, the combination of weekly nanoparticle albumin-bound-paclitaxel and carboplatin showed a 50% overall response rate and a median overall survival of 17.5 months, indicating significant efficacy.
The treatment was well tolerated, with no treatment-related deaths or febrile neutropenia reported, and it resulted in less neuropathic toxicity compared to traditional regimens, making it a promising option for elderly patients.
Phase II Study of Modified Carboplatin Plus Weekly Nab-Paclitaxel in Elderly Patients with Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301.Miyauchi, E., Inoue, A., Usui, K., et al.[2018]

Citations

Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. [2022]
The efficacy of carboplatin plus nanoparticle albumin-bound paclitaxel after cisplatin plus pemetrexed in non-squamous non-small-cell lung cancer patients. [2020]
Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer. [2015]
Phase II Study of Modified Carboplatin Plus Weekly Nab-Paclitaxel in Elderly Patients with Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301. [2018]
An Open-Label Randomized Controlled Trial Comparing the Efficacy and Safety of Pemetrexed-Carboplatin versus (Weekly) Paclitaxel-Carboplatin as First-Line Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer. [2021]
Carboplatin and nab-paclitaxel chemotherapy with or without atezolizumab as front-line management for treatment-naïve metastatic nonsquamous non-small cell lung cancer with PD-L1 staining: a retrospective study. [2023]
Single-agent pemetrexed for chemonaïve and pretreated patients with malignant pleural mesothelioma: results of an International Expanded Access Program. [2015]
Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). [2023]
Weekly albumin-bound paclitaxel/cisplatin versus gemcitabine/cisplatin as first-line therapy for patients with advanced non-small-cell lung cancer: A phase II open-label clinical study. [2022]
Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non-Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175. [2023]
Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
A Phase I/II Study of Necitumumab Plus Pembrolizumab, Nab-Paclitaxel, and Carboplatin for Previously Untreated Advanced Squamous Non-Small Cell Lung Cancer Study: (NEJ048A/NEXUS). [2023]
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