extensive-stage small cell lung cancer
Conditions
Interventions
Experimental group:Anlotinib + penpulimab + chemotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. 2. Aged 18 to 75 years, no gender limit. 3. Histologically or cytologically confirmed untreated extensive-stage small cell lung cancer (according to the American Legionnaires' Association for Lung Cancer VALG staging). 4. There is at least one measurable lesion that meets the RECISTv1.1 criteria, and the lesion can be considered as a measurable lesion only if there is clear disease progression after radiotherapy for the previously irradiated lesion, and the previously irradiated lesion is not the only lesion. 5. ECOG PS score: 0-1. 6. Expected survival period >= 3 months. 7. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening): (1) Routine blood examination: (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) hemoglobin (HB) >= 90 g/L, absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT) >= 100 x 10^9/L; white blood cell count (WBC) >= 3.0 x 10^9/L and = 30 g/L, thyroid-stimulating hormone (TSH)= 60 mL/min (Cockcroft-Gault formula). 8. Women of childbearing age must undergo a pregnancy test within 1 week before the first dose, and the result is negative. Female subjects and male subjects of childbearing age must agree to use a highly effective method of contraception during the study and within 120 days after the last dose of study drug. 9. Subjects who received prior chemoradiotherapy for limited-stage small cell lung cancer must be treated for the purpose of cure, and there is a treatment-free interval of at least 6 months from the diagnosis of extensive-stage small cell lung cancer to the last course of chemotherapy, radiotherapy or chemoradiotherapy.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical research treatment, or participating in other drug clinical trials within four weeks before the first administration. 2. It is expected that other anti-cancer treatment modalities, such as radiotherapy, will be required during treatment. However, subjects receiving prophylactic brain irradiation and palliative care other than thoracic radiation therapy after achieving disease remission or complete remission are excluded. 3. There are medical contraindications to etoposide and platinum-based chemotherapy, or previous severe hypersensitivity reactions to monoclonal antibody therapy. 4. Previous use of related immunotherapy drugs for PD-1, PD-L1, PD-L2 or any anti-angiogenic drugs or drugs for stimulating or co-inhibiting T cell receptors (eg CTLA-4, OX-40, CD137, GITR). 5. Subjects with known central nervous system metastases and/or cancerous meningitis. Unless asymptomatic or treated and stable, no imaging evidence of new brain metastases or brain metastases has been found for at least 2 weeks after treatment for brain metastases, subjects who had stopped steroids or anticonvulsants for at least 14 days prior to the start of study treatment were eligible for enrollment. If a subject has active or new untreated, asymptomatic CNS metastases on imaging during the screening period, radiation therapy or no therapy must be given and no imaging evidence of new brain metastases or brain metastases has been found for at least 2 weeks. 6. Past or concurrent with other malignant tumors (Except for basal cell carcinoma of the skin, apparent bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that achieved a complete response at least 5 years prior to screening and did not require or is expected to require no other treatment during the study period). 7. Imaging (CT or MRI) shows that the tumor lesion is = 150 mmHg or diastoli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recommended phaseII dose;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;objective response rate;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactChen Liang'an
Chinese PLA General Hospital
Outcome results
None listed