OncoMatch

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.

Phase 2RecruitingShanghai Chest HospitalNCT06698965Data as of May 2026

Treatment: Chemotherapy (Etoposide and Carboplatin) · Immunotherapy (Envafolimab) · TrilaciclibThis 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 qualify

Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify