Status and phase
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About
The phase II, randomised study is to explore the efficacy and safety of toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy
Enrollment
Sex
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Volunteers
Inclusion criteria
Provision of signed, written and dated informed consent prior to any study specific procedures;
Male or female aged 18-75 years;
Histologically- or cytologically-documented SCLC;
Stage I-III (AJCC/UICC 8th TNM Staging), with all lesions can be included in a tolerable radiotherapy field (limited-stage);
Previous thoracic radiotherapy (45 Gy twice daily or 60-66 Gy once daily) and concurrent etoposide and platinum for four cycles; Dose coverage ≥ 85% of PTV-GTV. Radiotherapy started before the completion of the third cycle of chemotherapy;
CR, PR or SD after concurrent chemoradiotherapy (RECIST v1.1);
PCI is allowed and should be completed within 90 days after the completion of chemoradiotherapy;
Randommization shoud be completed within 90 days after the completion of chemoradiotherapy;
Life expectancy ≥12 weeks;
World Health Organization (WHO) Performance Status of 0 or 1;
Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 7 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent);
Women must be non-breastfeeding;
Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study toripalimab treatment and for a period of 3 months following the last administration of the study treatment (i.e., 30 days [ovulation cycle] plus approximately 5 half-lives of the study drug);
Men who have sex with WOCBP must agree to comply with the contraceptive method during the study nivolumab treatment and for 5 months after the last administration of the study treatment (i.e. 90 days [sperm renewal cycle] plus approximately 5 half-lives of the study drug);
Spermless men do not have to comply with contraceptive requirements. WOCBP who continues to be asexual with the opposite sex does not have to comply with contraceptive requirements, but must still undergo the pregnancy tests described in this section;
Adequate organ and marrow function as defined below:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
170 participants in 2 patient groups
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Central trial contact
Bo Qiu; Hui Liu
Data sourced from clinicaltrials.gov
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