Actively Recruiting
QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC
Led by Anhui Provincial Cancer Hospital · Updated on 2026-01-09
96
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer is the leading cause of cancer-related deaths worldwide. According to the 2023 global cancer statistics, there are approximately 2.47 million new cases and 1.76 million deaths of lung cancer annually, accounting for 18.4% of all cancer deaths. Among them, driver gene negative NSCLC accounts for about 30% -40% of all NSCLC. In China, the incidence rate and mortality of lung cancer rank first. In 2022, there will be about 870000 new cases and 760000 deaths. In Chinese NSCLC patients, the EGFR mutation rate is about 50%, ALK fusion is about 5%, other mutations (ROS1, RET, etc.) are about 5% -10%, and the negative proportion of driver genes is about 30% -40%. Traditional treatment for late stage non-small cell lung cancer with negative driver genes has limited clinical efficacy. In recent years, the emergence of immune checkpoint inhibitors (ICIs) has greatly changed the treatment pattern of advanced non-small cell lung cancer patients, significantly prolonging the overall survival of advanced cancer patients. For the follow-up treatment of patients with previous immunotherapy, the current standard treatment regimen is still mainly chemotherapy. However, these plans have mediocre efficacy and significant side effects, making it difficult to meet the current clinical treatment needs. At present, there is no unified treatment plan for first-line immunotherapy or immunotherapy combined with chemotherapy in patients with driver gene negative advanced NSCLC. Second line chemotherapy such as docetaxel is currently recommended as the standard treatment plan in NCCN guidelines and CSCO guidelines. Research suggests that for patients with first-line immune resistance or immune combined chemotherapy resistance, second-line immune re challenge can still bring certain survival benefits to patients, but the benefits are limited and new treatment options need to be explored. Iparomlimab injection (drug number QL-1706) is a novel combination antibody independently developed by Qilu Company. It consists of Iparomlimab, an IgG4 antibody targeting PD-1, and Tuvonralimab, an IgG1 antibody targeting CTLA-4, in a fixed ratio. It has a synergistic mechanism of simultaneously blocking PD-1 and CTLA-4. In summary, ICIs are still an important treatment strategy for advanced non-small cell lung cancer. However, the emergence of drug resistance after immunotherapy seriously affects the survival time and prognosis of patients. Preliminary research has been conducted on the resistance mechanism of immunotherapy, but more research is needed to clarify the main mechanisms of action, in order to further prevent and overcome drug resistance. QL1706 has shown promising preliminary efficacy and good tolerability in PD-1 resistant NSCLC in preclinical and phase I clinical studies. Based on this, this study aims to conduct an exploratory study on QL1706 combined with chemotherapy compared to chemotherapy alone in the treatment of immune regulated non-small cell lung cancer with negative driver genes.
CONDITIONS
Official Title
QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with NSCLC confirmed by histology or cytology
- No EGFR sensitive mutations or ALK gene translocations
- Previously treated with PD-1/PD-L1 inhibitors plus platinum-based chemotherapy as first-line therapy and experienced disease progression
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 to 2
- Expected survival of at least 12 weeks
- Women of childbearing age must have a negative pregnancy test within 28 days before enrollment and agree to use contraception during and 8 weeks after treatment
- Men must agree to use contraception during and 8 weeks after treatment
- Laboratory tests show adequate organ function: neutrophils ≥1.5 x10^9/L, platelets ≥100 x10^9/L, hemoglobin ≥90 g/L, liver enzymes within defined limits, creatinine clearance ≥30 mL/min, coagulation within defined limits
- Patients deemed likely to benefit by researchers
You will not qualify if you...
- Presence of EGFR sensitive mutations or ALK gene translocations
- Prior treatment with PD-1/CTLA-4 bispecific antibodies
- Unresolved adverse reactions from previous treatments above grade 1 (except certain stable grade 2 toxicities)
- Symptomatic central nervous system metastases (unless treated and stable)
- Poorly controlled cancer-related pain or unstable effusions after treatment
- History of severe allergic reactions to study drugs or components
- Active autoimmune diseases except controlled type I diabetes, hypothyroidism, or mild skin diseases
- History of interstitial lung disease or drug-induced lung disease
- Recent use of systemic corticosteroids or immunosuppressants within 14 days before study drug
- History of immunodeficiency or organ transplantation
- Received live vaccines within 4 weeks before study drug
- Serious cardiovascular or cerebrovascular conditions within 6 months
- Positive HIV test or active hepatitis B or C infection not meeting specific criteria
- Other active cancers within 5 years except certain treated cancers
- History of substance abuse or mental disorders
- Pregnant or lactating women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui cancer hospital
Hefei, China
Actively Recruiting
Research Team
S
Shuanghu-Yuan Professor Yuan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here