Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110000, China
Location status: Recruiting
Location contact
Hongxu Liu
CONTACT
Hongxu Liu
PRINCIPAL_INVESTIGATOR
Jianxing He
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07122687
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Shenyang, Liaoning, 110000, China
Location status: Recruiting
Hongxu Liu
CONTACT
Hongxu Liu
PRINCIPAL_INVESTIGATOR
Jianxing He
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg/m2 D1 IV Q3W
75 mg/m2 D1 IV Q3W
1.5 mg/kg D1 IV Q3W
AUC 5 mg/ml/min D1 IV Q3W
200mg D1 IV Q3W
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Time frame: up to 90 days after the last dose
Time frame: up to 90 days after the last dose
Time frame: up to 90 days after the last dose
Time frame: up to 90 days after the last dose
Time frame: up to 90 days after the last dose
Time frame: up to 90 days after the last dose
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Time frame: up to 90 days after the last dose
Time frame: Up to approximately 5 years
EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Time frame: Up to approximately 5 years
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.
Time frame: Up to approximately 5 years
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease(SD) according to the RECIST v1.1 criteria.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
R0 resection rate is defined as negative margins, systematic lymph node dissection or sampling, and tumor-negative highest mediastinal lymph nodes.
Contact information is provided by the study sponsor or research team.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.