Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresecta… (NCT03872661) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC
China36 participantsStarted 2019-03-01
Plain-language summary
The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Target population is unresectable stage III non-small cell lung cancer.
* Written informed consent provided.
* Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
* Male and female patients aged ≥18 years, \< 75 years.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Life expectancy ≥12 weeks.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
* Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
* Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
* Known severe hypersensitivity to IBI308 or any of the excipients of this product.
* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
* Prior chemotherapy or radiotherapy.
* Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur …