Clinical trial · Interventional
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
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
NCT07122687CI-TRIAL-00119407recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| IBI363 | Drug | — | UNRESOLVED |
| Keytruda | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI363
- description
- Neoadjuvant Treatment period: 4 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: IBI363
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Keytruda
- description
- Neoadjuvant Treatment period: 4 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Keytruda
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.