Actively Recruiting
Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-07-31
62
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single-arm, phase 2 clinical trial assessing the feasibility, efficacy, and safety of the PD-L1 inhibitor Benmelstobart (TQB2450) as an adjuvant therapy regimen in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement.
CONDITIONS
Official Title
Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Age between 18 and 74 years at consent
- Pathologically confirmed stage IB lung adenocarcinoma (AJCC TNM 8th edition)
- Complete tumor removal (R0) after lobectomy, bilobectomy, or sleeve resection
- Pathological grade 3 invasive lung adenocarcinoma per IASLC 2020 grading system
- No prior anti-tumor treatments including chemotherapy, immunotherapy, or radiotherapy
- Expected survival longer than 12 weeks
- No active EGFR mutations or ALK rearrangements
- Tumor PD-L1 expression of at least 1%
- Enrolled within 4 to 12 weeks after surgery
- ECOG performance status 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Participants with childbearing potential must agree to use highly effective contraception from 7 days before first dose until 24 weeks after last dose
- Normal major organ function within 7 days before first dose
You will not qualify if you...
- Mixed histological tumor features after surgery
- Incomplete tumor removal (R1/R2), wedge resection, or segmentectomy
- Participation in other interventional trials or use of investigational drugs/devices within 4 weeks before first dose
- Continuous use of systemic corticosteroids or immunosuppressants for 7 days within 14 days before first dose
- Live vaccine administration within 28 days before first dose
- History or current interstitial lung disease requiring systemic corticosteroids
- History or current autoimmune disease
- Other cancers diagnosed within 5 years before first dose
- Uncontrolled cardiac, kidney, gastrointestinal, or infectious diseases
- History of allogeneic bone marrow or organ transplant
- Prior treatment with immune checkpoint inhibitors or anti-tumor vaccines
- History of severe allergic reactions to antibody drugs, uncontrolled asthma, or major drug allergies
- Pregnant or breastfeeding women
- Other conditions affecting safety or study compliance, including psychiatric disorders or moderate to large pleural effusions requiring repeated drainage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
H
Haoran E, MD
CONTACT
D
Deping Zhao, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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