New drug before lung cancer surgery shows promise in early trial
NCT ID NCT07402070
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called IBI363 given before surgery for people with stage II or III non-small cell lung cancer that can be removed. The goal is to see if the drug helps shrink or eliminate the tumor before the operation. About 10 participants will receive IBI363, and researchers will monitor safety and how well the cancer responds.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Feb 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and Females, age ≥18 years and ≤75 years; 2. Histologically or cytologically confirmed primary NSCLC: * Stage 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. PD-L1 expression: TPS≥1% 5. At least 1 measurable lesion per RECISIT v1.1; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1; 7. 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. Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug; 9. History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or severe impairment of pulmonary function or who are suspected to have these diseases by imaging during the screening period; 10. Active or uncontrolled diseases or conditions; 11. History of immunodeficiency disease; 12 Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Resectable stage II-III non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China