IBI363 or pembrolizumab plus chemotherapy before surgery for 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

This trial will see if giving IBI363 with chemotherapy or pembrolizumab with chemotherapy before surgery helps adults with resectable stage IB–III non-squamous non-small cell lung cancer and is safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: Pembrolizumab, Chemotherapy
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07122687 on ClinicalTrials.gov

What this trial studies

This randomized, open-label Phase 2 trial compares two neoadjuvant regimens—IBI363 plus platinum-based chemotherapy versus pembrolizumab (Keytruda) plus platinum-based chemotherapy—in adults with resectable stage IB–III non-squamous non-small cell lung cancer who lack EGFR or ALK alterations. Participants receive planned cycles of pemetrexed with cisplatin or carboplatin combined with either IBI363 or pembrolizumab prior to radical surgical resection. Eligible patients are 18–75 years old with ECOG 0–1, at least one measurable lesion per RECIST 1.1, and adequate organ function. The study tracks safety and anti-tumor activity to determine whether either regimen improves preoperative responses and surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with resectable stage IB–III non-squamous NSCLC, no EGFR or ALK alterations, ECOG performance status 0–1, measurable disease, and adequate organ function who can tolerate lung resection.

Not a fit: Patients with EGFR mutations or ALK translocations, predominant squamous histology, symptomatic tumor invasion of critical structures, poor performance status, or insufficient organ function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the regimen could shrink tumors more effectively before surgery and potentially improve recurrence-free and overall outcomes.

How similar studies have performed: Other trials combining PD-1/PD-L1 inhibitors like pembrolizumab with chemotherapy before surgery have shown encouraging responses, while IBI363 is a newer investigational agent with limited published neoadjuvant data.

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 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 RECISIT 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.

Where this trial is running

Shenyang, Liaoning

• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: wei zhang

Conditions Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer