Status:
COMPLETED
A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) ...
Eligibility Criteria
Inclusion
- Signed the Informed Consent Form;
- Male or female ≥ 18 and≤75 years of age;
- Life expectancy ≥ 12 weeks;
- Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging;
- At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression.
Exclusion
- Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy;
- Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug;
- Received any investigational agent within 4 weeks prior to the first dose of study drug;
- Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
- Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
- Pregnant or breastfeeding woman.
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04672928
Start Date
December 14 2020
End Date
January 31 2023
Last Update
February 27 2023
Active Locations (1)
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1
Jilin Povince Cancer Hospital
Changchun, Jilin, China