Resectable Stage II-IIIa Squamous NSCLC
Conditions
Keywords
lung cancer, immunotherapy
Brief summary
This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.
Interventions
Serplulimab injection \[300 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles
Nivolumab \[360 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years and ≤ 75 years at time of study entry. 2. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology. 3. The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology; 4. Able to tolerate complete lung cancer resection; 5. WHO/ECOG performance status of 0 or 1.
Exclusion criteria
1. Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma. 2. EGFR sensitivity mutation or ALK, ROS1 gene rearrangement; 3. Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs; 4. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete remission (PCR) rate | From randomization up to a median of 30 months after randomization | Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator. |
Countries
China
Outcome results
None listed