A Phase 2 interventional study of QL1706 combined with Chemotherapy and Chemotherapy in NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by Anhui Provincial Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Anhui Provincial Cancer Hospital · Phase 2, Interventional, and Treatment
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.
This study is a prospective, multicenter, open label randomized controlled trial design, recruiting 96 immunocompromised driver gene negative patients with locally advanced or recurrent/metastatic non-small cell lung cancer. The experimental group received QL1706 combined with docetaxel or gemcitabine treatment in a 1:1 ratio, while the control group received docetaxel or gemcitabine treatment.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 96 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Anhui Provincial Cancer Hospital is the lead sponsor of 24 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
QL1706：5mg/kg，iv，d1 combined with Gemcitabine (1000mg/m2，iv，d1、d8 )or DOCETAXEL (60mg/m2，iv，d1)
Drug: QL1706 combined with Chemotherapy
Gemcitabine (1000mg/m2，iv，d1、d8 )or DOCETAXEL (60mg/m2，iv，d1)
Drug: Chemotherapy
QL1706：5mg/kg，iv，d1 combined with Gemcitabine (1000mg/m2，iv，d1、d8 )or DOCETAXEL (60mg/m2，iv，d1)
Gemcitabine (1000mg/m2，iv，d1、d8 )or DOCETAXEL (60mg/m2，iv，d1)
PFS
Refers to the time from the start of medication to the first occurrence of disease progression or death from any cause
Time frame: "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"
ORR
It refers to the proportion of patients whose tumor volume shrinks by 30% and can be maintained for more than four weeks, that is, the proportion of subjects who achieve complete response (CR) and partial response (PR)
Time frame: through study completion, an average of 1 year
DCR
It refers to the proportion of subjects who achieve complete remission (CR), partial remission (PR), and disease stability (SD) at the end of treatment
Time frame: through study completion, an average of 1 year
DOR
Refers to the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD)
Time frame: through study completion, an average of 1 year
OS
It refers to the time from the start of medication to death caused by any reason
Time frame: through study completion, an average of 1 year
AE
AE
Time frame: through study completion, an average of 1 year
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Carcinoma, Non-Small-Cell Lung→
Anhui Provincial Cancer Hospital