A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

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

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

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

• 18 to 75 years old, both male and female;

• ECOG score: 0-1;

• Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

• Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

• Measurable lesions available;

• Major organ function is basically normal;

• Estimated survival time is at least 6 months;

• Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Contact Information
Primary
Huai Liu, MD
liuhuai@hnca.org.cn
+8619918909231
Time Frame
Start Date: 2023-06-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 41
Treatments
Experimental: Interventional arm
Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.
Sponsors
Leads: Hunan Cancer Hospital

This content was sourced from clinicaltrials.gov