IBI363 or pembrolizumab plus chemotherapy before surgery for resectable stage IB–III non-squamous non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Liaoning Cancer Hospital and Institute
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: xiao zhang
• Email: kobe.zhang@innoventbio.com
• Phone: 17631117415

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Peripheral neuropathy during perioperative therapy with enfortumab vedotin and pembrolizumab in muscle-invasive urothelial cancer

  This study follows adults with muscle-invasive urothelial cancer to see how nerve-related side effects develop when people receive enfortumab vedotin and pembrolizumab around surgery as part of standard care.

  Recruiting at 3 sites Comprehensive Cancer Center Munich (CCCM) · Munich, Bavaria and 2 other locations · NCT07870577

• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

  This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin in untreated locally advanced or metastatic urothelial cancer

  This trial tests if adding ivonescimab to enfortumab vedotin works better than pembrolizumab plus enfortumab vedotin for people with untreated locally advanced or metastatic urothelial cancer.

  Recruiting at 2 sites Phase 2/3 Summit Therapeutics · Phoenix, Arizona and 6 other locations · NCT07815665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.