NCT07330596

QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC

Recruiting now Phase 2 Last updated 9 January 2026

What this trial tests

Phase 2 trial testing QL1706 combined with Chemotherapy in NSCLC (Advanced Non-small Cell Lung Cancer) in 96 participants. Currently enrolling.

Timeline

30 October 2025

Primary endpoint
28 January 2028

28 February 2028

Quick facts

Lead sponsor	Anhui Provincial Cancer Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	30 October 2025
Primary completion	28 January 2028
Estimated completion	28 February 2028
Sites	1 location across China

Drugs / interventions tested

• QL1706 combined with Chemotherapy — full drug profile →
• Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

• NSCLC (Advanced Non-small Cell Lung Cancer) — all drugs for NSCLC (Advanced Non-small Cell Lung Cancer) →

Sponsor

Anhui Provincial Cancer Hospital

Who can join

Adults 18 to 75, any sex, with NSCLC (Advanced Non-small Cell Lung Cancer). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.