Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07452003
Brief Summary:
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.
Detailed Description:
Patients with stage IIB-IIIB NSCLC have a substantial risk of recurrence after surgery, and perioperative systemic therapy is used to improve long-term outcomes. Immune checkpoint blockade combined with chemotherapy has improved pathologic response rates in resectable NSCLC; however, a proportion of patients-especially those with low PD-L1 expression-may derive limited benefit from single-pathway blockade. QL1706 is a bispecific antibody targeting PD-1 and CTLA-4 intended to enhance antitumor immunity through dual checkpoint inhibition. This study explores the feasibility, pathologic response, and longer-term clinical outcomes of adding perioperative QL1706 to standard platinum-based chemotherapy in a resectable/potentially resectable population.
All participants will receive three cycles of neoadjuvant QL1706 plus chemotherapy every 21 days, followed by radiographic assessment and surgical evaluation. Safety will be monitored throughout treatment and for 28 days after the last dose, with special attention to immune-related adverse events. After surgery, participants will be followed for recurrence and survival. Tumor tissue and peripheral blood will be collected at protocol-defined timepoints for exploratory biomarker studies (e.g., PD-L1 and immune cell profiling, TCR/BCR repertoire sequencing, transcriptomic/proteomic analyses), aiming to characterize immune changes associated with response, resistance, and immune-related toxicities and to develop predictive models for benefit and risk.
Study:
NCT07452003
Study Brief:
Protocol Section:
NCT07452003