Actively Recruiting
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
Led by Immune Oncology Research Institute · Updated on 2025-05-08
45
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
I
Immune Oncology Research Institute
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment.
CONDITIONS
Official Title
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and immunohistochemically confirmed metastatic NSCLC with no prior treatment for metastatic disease
- Negative for actionable EGFR mutations and ALK rearrangements
- Recurrence after prior treatment for non-metastatic disease allowed if recurrence is more than 6 months after treatment
- Provided documented informed consent
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Measurable metastatic disease according to RECIST 1.1 and iRECIST guidelines
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN), except Gilbert syndrome patients ≤ 3.0 times ULN
- AST ≤ 2.5 times ULN or ≤ 5 times ULN if liver metastases present
- ALT ≤ 2.5 times ULN or ≤ 5 times ULN if liver metastases present
- Creatinine clearance ≥ 45 ml/min
- Alkaline phosphatase ≤ 3 times ULN
- Hemoglobin ≥ 9 g/dl
- Absolute neutrophil count ≥ 1500/µl
- Platelets ≥ 100,000/mm³
- Albumin ≥ 3.0 g/dl
- Women of childbearing potential must have a negative pregnancy test
- Male and female patients of reproductive potential must use effective contraception or abstain from sexual activity during and for 90 days after treatment
- Willing and able to comply with study requirements
You will not qualify if you...
- Prior treatment with anti-CTLA-4 and anti-PD-(L)1 therapies (except prior anti-PD-(L)1 in adjuvant setting if recurrence >6 months after)
- Use of systemic corticosteroids >10 mg prednisone equivalent within 14 days or other immunosuppressive medication within 30 days before first study dose
- Prior allogeneic organ transplant
- Recent surgery within 4 weeks before treatment, except minor procedures
- Allergic reactions to study drug components
- Active or recent autoimmune disease requiring systemic treatment within 2 years
- Active significant cardiovascular disease or unstable heart conditions
- Persistent toxicities from prior cancer therapy grade 2 or higher (with some exceptions)
- Active or untreated brain metastases
- Concurrent or recent malignancies requiring treatment within 2 years
- Current or prior interstitial lung disease or pneumonitis requiring steroids
- Psychiatric or substance abuse disorders interfering with study participation
- Conditions or infections that may interfere with study results or participation
- COVID-19 vaccine or booster within 7 days before first treatment dose
- Uncontrolled HIV infection; stable HIV allowed
- Active hepatitis B or C infections unless virus-free for at least 180 days
- Active tuberculosis
- Grade 3 or above neuropathy
- Dependence on total parenteral nutrition or intravenous hydration
- Any other condition that contraindicates participation due to safety concerns
- Inability to comply with all study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hematology Center named after prof. R. Yeolyan
Yerevan, Armenia, 0014
Actively Recruiting
Research Team
S
Samvel Bardakhchyan, MD, PhD
CONTACT
A
Amalya Sargsyan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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