The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC (NCT05904015) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC
80 participantsStarted 2023-08-01
Plain-language summary
To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The result of histopathological or cytological diagnosis is small cell lung cancer.
* Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard.
* Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy.
* Age 18-75 years old, male or non pregnant female.
* The expected survival period is\>3 months.
* ECOG score 0-1.
* Weight\>30 kilograms.
* All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify.
* Hematological indicators: white blood cell (WBC) count ≥ 4 \* 109/L, absolute neutrophil count (ANC) ≥ 1.5 \* 109/L, hemoglobin (Hb) level\>100 g/L, platelet (Plt) count\>100 \* 109/L, serum creatinine (Cr) level\<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels\<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value.
* The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan.
Exclusion Criteria:
* Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology…
What they're measuring
1
2-year PFS rate
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
Trial details
NCT IDNCT05904015
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences