Actively Recruiting
Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
Led by Shanghai Chest Hospital · Updated on 2024-11-21
52
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
Sponsors
S
Shanghai Chest Hospital
Lead Sponsor
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Small cell lung cancer confirmed by histology or cytology
- Extensive-stage small cell lung cancer classified as stage IV or T3-4 with multiple nodules or large tumor volume
- At least one measurable lesion on imaging per RECIST 1.1
- No prior systemic anti-tumor treatment for extensive-stage disease; prior adjuvant/neoadjuvant chemo or curative radiotherapy allowed if at least 6 months since last treatment
- Patients with asymptomatic or stable brain metastases
- Allowed palliative radiation therapy completed at least one week before enrollment
- Laboratory values meeting required thresholds for hemoglobin, neutrophils, platelets, kidney and liver function, albumin, coagulation, thyroid hormone, and heart enzymes
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Female participants of childbearing potential must have a negative pregnancy test during screening and use reliable contraception until 3 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Other malignant diseases (except certain skin cancers) within 5 years prior to first dose
- Mixed small cell and non-small cell lung cancer confirmed by histology or cytology
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks prior to first dose
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or T-cell receptor modulators
- Use of systemic traditional Chinese medicines or immunomodulatory drugs within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose
- Systemic corticosteroid or immunosuppressive therapy within 7 days prior to first dose (physiological doses allowed)
- Known allergy to study drugs or their components
- Clinically uncontrollable pleural or peritoneal effusion
- Known HIV infection or untreated active hepatitis B or C
- Pregnant or lactating female participants
- Uncontrolled ischemic heart disease or severe congestive heart failure (NYHA class III or IV)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
H
Hua Zhong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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