New combo therapy aims to shrink lung tumors before surgery
NCT ID NCT07286942
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new approach for people with early-stage non-small cell lung cancer that can be removed with surgery. Before surgery, patients receive a combination of targeted radiation (SBRT), two immunotherapy drugs (iparomlimab and tuvonralimab, also called QL1706), and chemotherapy. The goal is to see if this treatment can make the tumor disappear completely by the time of surgery. The study will enroll 24 adults in China and will also track side effects and long-term outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily participates in the study and provides written informed consent; 2. Aged 18-75 years, with no restriction on sex; 3. Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC); 4. Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix 2 for scoring criteria); 6. Considered by the thoracic surgeon to have adequate pulmonary reserve to tolerate the planned lung resection; 7. Availability of tumor tissue prior to enrollment for pathological confirmation of EGFR/ALK wild-type status and PD-L1 expression assessment; 8. No significant hematologic, cardiac, pulmonary, hepatic, renal, or immunologic dysfunction, with the following laboratory parameters meeting the specified criteria: * Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥9 g/dL; * Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× ULN; * Renal function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L; 9. Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study treatment. Exclusion Criteria: * 1\. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease. 2\. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma. 3\. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status). 4\. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents. 5\. Active infection, or unexplained fever \>38.5 °C within 2 weeks prior to screening (participants with tumor-related fever, as judged by the investigator, may be enrolled). 6\. Male or female participants of reproductive potential who are unwilling to use effective contraception during the study; pregnant or breastfeeding women. 7\. Any condition that, in the opinion of the investigator, could interfere with study participation or completion, including severe comorbidities (including psychiatric disorders) requiring concurrent treatment, or family or social factors that may compromise participant safety or data integrity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- Can a new targeted drug shrink lung tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug combo revive the immune System's attack on resistant cancers?
- Can a targeted pill after surgery keep early lung cancer from returning?