Actively Recruiting
An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC
Led by Peking Union Medical College Hospital · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, single-arm phase II exploratory study evaluating a perioperative regimen of iparomlimab and tuvonralimab (QL1706; a bispecific PD-1/CTLA-4 antibody) combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage IIB-IIIB non-small cell lung cancer (NSCLC) without actionable driver alterations. Approximately 30 eligible participants will receive three 21-day cycles of neoadjuvant QL1706 plus chemotherapy, followed by surgical resection if feasible. After surgery, participants will be followed regularly to assess pathologic response, recurrence, survival outcomes, and safety, including immune-related adverse events. The primary efficacy endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor in the resected specimen. Secondary endpoints include event-free survival, overall survival, objective response rate, disease control rate, and R0 resection rate. Exploratory analyses will evaluate changes in the tumor immune microenvironment and peripheral immune profiles using tumor tissue and blood samples, including T-cell and B-cell receptor repertoire analyses and multi-omics profiling, with the goal of developing models to predict treatment benefit and immune-related toxicity risk.
CONDITIONS
Official Title
An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Confirmed diagnosis of non-small cell lung cancer (NSCLC) by histology.
- At least one measurable tumor lesion as defined by RECIST 1.1 criteria.
- No prior systemic or local treatment for NSCLC.
- TNM stage IIB to IIIB disease, assessed as resectable or potentially resectable by surgeons.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Normal pulmonary function.
- Adequate blood counts and organ function based on recent laboratory tests.
- Women of childbearing potential must agree to use effective contraception or abstain from heterosexual intercourse during treatment and for 6 months after.
- Male participants must agree to abstain or use effective contraception and not donate sperm during treatment and for 6 months after.
- Voluntary participation with informed consent and willingness to comply with study procedures and follow-up.
You will not qualify if you...
- Prior treatment with any immunotherapy.
- ECOG performance status greater than 1.
- Evidence of distant metastasis or intrathoracic metastatic disease.
- Presence of actionable driver gene mutations with available targeted therapies.
- Pregnant or breastfeeding women.
- Known allergy or intolerance to PD-1 monoclonal antibodies or related components.
- Major surgery within 4 weeks prior to study treatment or incomplete wound healing.
- Significant cardiovascular or cerebrovascular disease within recent months.
- Severe liver or kidney dysfunction.
- Active, moderate to severe infections.
- Active or recent history of autoimmune diseases needing systemic immunosuppressive therapy.
- Prior or planned organ or bone marrow transplantation.
- Active tuberculosis or other infections.
- Known HIV infection.
- Severe non-healing wounds or fractures.
- Substance abuse or medical, psychological, or social conditions interfering with study participation.
- Unresolved toxicities above grade 1 from prior treatments, except certain conditions.
- Severe pulmonary dysfunction or interstitial lung diseases.
- Concurrent or recent other malignancies except certain treated skin or localized cancers.
- Any condition judged by the investigator as unsuitable for study participation.
- Concurrent enrollment in another clinical trial.
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
B
binhe Tian
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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