New drug combo aims to shrink lung tumors before surgery
NCT ID NCT07122687
First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether adding an experimental drug (IBI363) or the approved drug Keytruda to standard chemotherapy can better shrink tumors before surgery in people with stage IB to III non-squamous lung cancer. About 170 participants will be randomly assigned to one of two treatment groups. The main goals are to see how many patients have no cancer left after treatment and to check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI363 (an experimental immunotherapy) and pembrolizumab (Keytruda, an approved immunotherapy)
- What this could lead to
- If it works, this could point toward a better way to shrink lung tumors before surgery, potentially improving long-term outcomes.
- What could go wrong
- This is a mid-stage trial with only 170 people, so results may not apply to everyone. Side effects from immunotherapy and chemotherapy can be serious.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Liaoning Cancer Hospital and Institute
RECRUITINGShenyang, Liaoning, 110000, China