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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

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

• 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.

• Participants without EGFR mutations or ALK translocation;

• At least 1 measurable lesion per RECISIT v1.1;

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;

• Adequate organ function confirmed at screening period.

Locations
Other Locations
China
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Contact Information
Primary
wei zhang
wei.zhang02@innoventbio.com
15005136320
Time Frame
Start Date: 2025-08-26
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 170
Treatments
Experimental: IBI363
Neoadjuvant Treatment period: up to 3 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.
Active_comparator: Keytruda
Neoadjuvant Treatment period: up to 3 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.
Sponsors
Leads: Innovent Biologics (Suzhou) Co. Ltd.

This content was sourced from clinicaltrials.gov