New drug combo aims to fight lung cancer without chemo
NCT ID NCT06322108
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether two immunotherapy drugs, balstilimab and botensilimab, are safe and effective as a first treatment for people with metastatic non-small cell lung cancer. The trial includes 45 participants who have not had prior treatment for advanced disease. Researchers will track how long patients live without their cancer getting worse, and how many respond to the drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- balstilimab and botensilimab (immunotherapy drugs)
- What this could lead to
- If successful, this combination could offer a new first-line immunotherapy option for people with metastatic non-small cell lung cancer, potentially improving survival without chemotherapy.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 45 participants, so results may not apply to everyone. Immunotherapy can cause serious side effects like inflammation of organs, and the combination may not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically and IHC confirmed diagnosis of metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease. 2. Negative for actionable EGFR mutations and ALK rearrangements. 3. Patients with recurrence after prior neoadjuvant or adjuvant chemotherapy or radiation therapy or immune checkpoint inhibitors for non-metastatic disease are eligible if recurrence occurred \>6 months after the end of neoadjuvant or adjuvant treatment. 4. Documented informed consent of the participant and/or legally authorized representative 5. ≥ 18 years of age. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy ≥ 3 months. 8. Patients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST guidelines. 9. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 7 days prior to day 1 of protocol therapy) (except subjects with Gilbert syndrome who must have a total bilirubin level of ≤3.0 × ULN). 10. Aspartate aminotransferase (AST) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy). 11. Alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy). 12. Creatinine clearance ≥ 45 ml/min (within 7 days prior to day 1 of protocol therapy). 13. Alkaline phosphatase ≤ 3 x ULN (within 7 days prior to day 1 of protocol therapy). 14. Hemoglobin ≥ 9 g/dl (within 7 days prior to day 1 of protocol therapy). 15. Absolute neutrophil count (ANC) ≥ 1500/ul (within 7 days prior to day 1 of protocol therapy). 16. Platelets ≥ 100,000/mm\^3 (within 7 days prior to day 1 of protocol therapy). 17. Albumin ≥ 3.0 g/dl (within 7 days prior to day 1 of protocol therapy). 18. Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to day 1 of protocol therapy) a) Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation. 19. Male and female patients of reproductive potential must use effective methods of contraception (defined in Appendix A) or abstain from sexual activity for the course of the study through at least 90 days after the last dose of balstilimab and/or botensilimab 20. Is willing and able to comply with the requirements of the protocol. Exclusion Criteria: 1. Prior treatment with anti-CTLA-4 and anti-PD-(L)1 therapy. Note: Prior treatment with anti-PD-(L)1 therapy in the adjuvant setting is permitted if recurrence occurred \>6 months after the end of adjuvant treatment. 2. Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid dose ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 3. Prior allogeneic organ transplantation. 4. Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement. 5. Prior allergic reaction or hypersensitivity to any of the study drug components. 6. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs. 7. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), serious uncontrolled cardiac arrhythmia requiring medication. a. QTcF (QTc interval corrected using Fridericia's formula) of \> 480 ms. 8. Any persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≥ 2) from prior cancer therapy, excluding endocrinopathies stable on medication, stable neuropathy that is grade 2 or less, and alopecia. 9. Active brain metastases or leptomeningeal metastases with the following exceptions: a. Treated brain metastases require a) surgical resection, or b) stereotactic radiosurgery. Whole-brain radiation is not allowed. Subjects must have also discontinued steroid treatment 28 days prior to enrollment for the purpose of managing their brain metastases and they must be asymptomatic and radiologically stable ≥28 days before enrollment. 10. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 730 days (or 2 years) prior to enrollment, i.e., subjects with a history of prior malignancy are eligible if treatment was completed at least 730 days (or 2 years) before enrollment and the subject has no evidence of disease. Subjects with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible. 11. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids. 12. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 13. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \< 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study. 15. Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required. 16. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Subjects who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 180 days prior to enrollment are eligible. Serological testing for HBV at screening is not required. 17. Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Subjects on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 180 days prior to enrollment. Serological testing for HCV at screening is not required. 18. Known active tuberculosis. Tuberculosis testing at screening is required. 19. Grade 3 or above neuropathy at the time of enrollment. 20. Dependence on total parenteral nutrition or intravenous hydration. 21. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. 22. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hematology Center named after prof. R. Yeolyan
Yerevan, 0014, Armenia
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Other studies related to the condition(s) this trial covers.
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