Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Age ≥18 years old, both male and female are acceptable.
always has not received the immune therapy,
Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS > 3 months, withdrawal time > 3 months)
never used anlotinib,
Disqualifiers
1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;
2.With known the special ripley sheet resistance, etoposide contraindication;
3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
Trial design
Design model
Parallel
Treatments tested in this trial
Toripalimab; Etoposide
DrugToripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； carboplatin: AUC=5，d1， ivgtt,， Q3W； temozolomide:75mg/m2/d，d1-d21，PO，Q4W; Anlotinib:12mg，d1-d14 PO，Q3W
Treatment groups
130 Participants
are divided into 5 treatment groupsGroup A: EtoposideExperimental treatment 1 intervention
Group B: Etoposide+ToripalimabExperimental treatment 1 intervention
Group C: Toripalimab+Etoposide+AnlotinibExperimental treatment 1 intervention
Group D: Toripalimab+Etoposide+CarboplatinExperimental treatment 1 intervention
Group E: Etoposide+Toripalimab+TemozolomideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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