Actively Recruiting
A Randomized Phase II Study of Trilaciclib, Envafolimab, Etoposide, and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2024-11-21
52
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of a combination therapy involving Trilaciclib, Envafolimab, Etoposide, and Carboplatin for first-line treatment in patients with extensive-stage small cell lung cancer (SCLC). This phase II randomized controlled study also examines how Trilaciclib may affect the occurrence of myelosuppression and tumor response. The trial is sponsored by Shanghai Chest Hospital and aims to better understand treatment options for this advanced lung cancer stage. Participants are assigned to one of two groups. The TEC Group receives Envafolimab combined with Etoposide and Carboplatin for six cycles, plus Trilaciclib before each chemotherapy session. After six cycles, this group continues with Trilaciclib and Envafolimab as maintenance therapy for up to two years or until disease progression or intolerable side effects. The EC Group receives the same chemoimmunotherapy for six cycles but continues only Envafolimab as maintenance therapy under the same conditions. Dosing schedules are every three weeks, with chemotherapy given intravenously and Envafolimab by subcutaneous injection. During the study, participants undergo regular evaluations including monitoring for neutropenia, thrombocytopenia, anemia, and other blood-related side effects throughout the chemotherapy cycles. Researchers also assess tumor response, survival outcomes, and use of supportive treatments like growth factors and transfusions. The main outcome measured is the rate of severe neutropenia during chemotherapy, with follow-up up to 60 months for progression and survival data. The study includes safety monitoring and continues until treatment intolerance, disease progression, withdrawal, or a maximum of two years.
CONDITIONS
Brief 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
- Confirmed diagnosis of small cell lung cancer by biopsy or cytology
- Extensive-stage disease classified as stage IV or advanced pulmonary involvement
- At least one measurable tumor lesion on imaging
- No prior systemic anti-tumor treatment for extensive-stage disease
- Patients with stable or asymptomatic brain metastases
- Completed any palliative radiation therapy at least one week before enrollment
- Laboratory tests meeting specified blood counts, kidney, liver, and thyroid function requirements
- 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 and use contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of other malignant diseases within 5 years (except certain skin cancers)
- Mixed small cell and non-small cell lung cancer
- Participation in other interventional clinical trials or recent use of investigational drugs/devices
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or T cell modulating drugs
- Recent use (within 2 weeks) of systemic treatments with traditional Chinese medicines or immunomodulatory drugs
- Active autoimmune disease requiring systemic treatment within past 2 years
- Systemic corticosteroid or immunosuppressive therapy within 7 days before study start (low-dose corticosteroids allowed)
- Known allergies to study drugs or excipients
- Clinically uncontrollable pleural or peritoneal effusion
- Known HIV infection or untreated active hepatitis B or C
- Pregnant or breastfeeding females
- Uncontrolled ischemic heart disease or severe heart failure (NYHA class III or IV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive a combination of Trilaciclib, Envafolimab, Etoposide, and Carboplatin as first-line treatment for extensive-stage small cell lung cancer. This includes 6 cycles of chemotherapy with Trilaciclib given before each chemotherapy session in the TEC Group, or chemotherapy with Envafolimab without Trilaciclib in the EC Group. Each cycle lasts 21 days.
6 cycles, each lasting 21 days
Duration - Up to 2 years
After completing 6 cycles of chemotherapy, participants continue maintenance therapy. The TEC Group receives Trilaciclib in combination with Envafolimab, while the EC Group receives Envafolimab alone. Maintenance continues until disease progression, intolerable side effects, withdrawal, or up to 2 years.
Regular visits for maintenance therapy as per protocol
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
H
Hua Zhong, MD
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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