OncoMatch/Clinical Trials/NCT06698965
Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
Is NCT06698965 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chemotherapy (Etoposide and Carboplatin) and Immunotherapy (Envafolimab) for lung cancer, small cell.
Treatment: Chemotherapy (Etoposide and Carboplatin) · Immunotherapy (Envafolimab) · Trilaciclib — This prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV, T3-4 DUE TO MULTIPLE PULMONARY NODULES OR TUMOR/NODULE VOLUME TOO LARGE TO BE INCLUDED IN A TOLERABLE RADIOTHERAPY PLAN (AJCC 8th edition)
Metastatic disease required
Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-pd-1/pd-l1/pd-l2 or co-inhibitory t-cell receptor therapy
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L
Kidney function
Creatinine clearance rate (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5x ULN; ALT and AST ≤ 3x ULN or ≤ 5x ULN (for patients with liver metastases); albumin ≥ 30 g/L
Cardiac function
Myocardial enzyme profile within normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included)
The laboratory test results meet the following criteria: Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; Creatinine clearance rate (CrCl) ≥ 60 mL/min (as calculated using the Cockcroft-Gault formula); Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases); albumin ≥ 30 g/L; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; Thyroid stimulating hormone (TSH) is within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; The myocardial enzyme profile is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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