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Tests treatment safety and results for Lung Cancer, Small Cell
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
ClinicalTrials.gov ID: NCT06698965
What this study is testing
What is Chemotherapy （Etoposide and Carboplatin）?
Chemotherapy （Etoposide and Carboplatin） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer, small cell.
Also referred to as Etoposide+Carboplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, regardless of gender;
- Small cell lung cancer (SCLC) confirmed by histology or cytology;
- 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...
- At least one measurable lesion on imaging（RECIST 1.1）;
- Have not received any systemic anti-tumor treatment for extensive-stage diseases in the past. For patients who have received adjuvant/neoadjuvant...
You likely can't join if
- Diagnosed with malignant diseases other than SCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous...
- Mixed SCLC and NSCLC confirmed by histology or cytology;
- Currently participating in treatment clinical research treatment, or having received other investigational drugs or used investigational devices...
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell...
- Within 2 weeks before the first administration, the individual has received systematic systemic treatment with traditional Chinese patent medicines...
- Within 2 years prior to the first administration, the individual has been an active autoimmune disease requiring systemic treatment (such as the use...
See the full eligibility criteria
- Age ≥ 18 years, regardless of gender;
- Small cell lung cancer (SCLC) confirmed by histology or cytology;
- 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...
- At least one measurable lesion on imaging（RECIST 1.1）;
- Have not received any systemic anti-tumor treatment for extensive-stage diseases in the past. For patients who have received adjuvant/neoadjuvant chemotherapy in the past, or have received curative radiotherapy and...
- Patients with asymptomatic brain metastases or brain metastases whose symptoms have stabilized after treatment;
- people are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases), but the radiation therapy must be completed at least one week before enrollment;
- 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...
- ECOG PS score 0 or 1;
- Expected survival time ≥ 3 months;
- For Female Participants: All Female Participants with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the...
- Understand and sign the informed consent form.
- Diagnosed with malignant diseases other than SCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Mixed SCLC and NSCLC confirmed by histology or cytology;
- Currently participating in treatment clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- Within 2 weeks before the first administration, the individual has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti lung cancer indications or drugs with...
- Within 2 years prior to the first administration, the individual has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants)...
- Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other...
- Individuals who are known to be allergic to the active ingredients or excipients of the investigational drugs, such as trilaciclib, envafolimab, etoposide, carboplatin, etc;
- Patients with clinically uncontrollable pleural/peritoneal effusion (those who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days can be enrolled);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive) or untreated active HBV, HCV;
- Pregnant or lactating female participants;
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV)
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.