IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Males and Females, age ≥18 years and ≤75 years;

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.

Disqualifiers

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;

Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;

Pancoast tumor;

Malignant tumor nodule in the contralateral lung lobe;

Trial design

Treatments tested in this trial

  • Pemetrexed
  • Cisplatin
  • IBI363
  • Carboplatin
  • Keytruda

Treatment groups

170 Participants
are divided into 2 treatment groups