IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Recruiting
Phase 2Interventional Study
Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Males and Females, age ≥18 years and ≤75 years;
2. Histologically or cytologically confirmed primary non-squamous NSCLC:
* Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
* No administration of any anti-NSCLC therapy in the pre-operative period;
* Be able to unde…
Inclusion Criteria:
1. Males and Females, age ≥18 years and ≤75 years;
2. Histologically or cytologically confirmed primary non-squamous NSCLC:
* Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
* No administration of any anti-NSCLC therapy in the pre-operative period;
* Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
3. Participants without EGFR mutations or ALK translocation;
4. At least 1 measurable lesion per RECIST v1.1;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
6. Adequate organ function confirmed at screening period.
Exclusion Criteria:
1. Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
2. Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
3. Pancoast tumor;
4. Malignant tumor nodule in the contralateral lung lobe;
5. Participants with known or suspected brain metastases or other distant metastases;
6. Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
7. Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
8. History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
9. History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
10. History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
11. Active or uncontrolled diseases or conditions;
12. History of immunodeficiency disease;
13. Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.