OncoMatch/Clinical Trials/NCT06322108
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
Is NCT06322108 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Botensilimab + Balstilimab for non-small cell lung cancer.
Treatment: Botensilimab + Balstilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Metastatic disease required
metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-CTLA-4 therapy
Exception: Prior anti-PD-(L)1 therapy in the adjuvant setting is permitted if recurrence occurred >6 months after the end of adjuvant treatment.
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.
Cannot have received: anti-PD-1 therapy
Exception: Prior anti-PD-(L)1 therapy in the adjuvant setting is permitted if recurrence occurred >6 months after the end of adjuvant treatment.
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.
Cannot have received: anti-PD-L1 therapy
Exception: Prior anti-PD-(L)1 therapy in the adjuvant setting is permitted if recurrence occurred >6 months after the end of adjuvant treatment.
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.
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dl; ANC ≥ 1500/ul; Platelets ≥ 100,000/mm^3; Albumin ≥ 3.0 g/dl
Kidney function
Creatinine clearance ≥ 45 ml/min
Liver function
Total bilirubin ≤ 1.5 x ULN (≤3.0 × ULN for Gilbert syndrome); AST ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); alkaline phosphatase ≤ 3 x ULN
Cardiac function
QTcF > 480 ms excluded; NYHA class ≥ III heart failure, recent MI or stroke, serious arrhythmia excluded
Total bilirubin ≤ 1.5 x ULN (except Gilbert syndrome ≤3.0 × ULN); AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); alkaline phosphatase ≤ 3 x ULN; Creatinine clearance ≥ 45 ml/min; Hemoglobin ≥ 9 g/dl; ANC ≥ 1500/ul; Platelets ≥ 100,000/mm^3; Albumin ≥ 3.0 g/dl; QTcF > 480 ms excluded; NYHA class ≥ III heart failure, recent MI or stroke, serious arrhythmia excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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