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New Immune-Chemo cocktail aims to shrink inoperable lung tumors
NCT ID NCT07082179
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of two immune-boosting antibodies (iparomlimab and tuvonralimab) plus chemotherapy for people with stage III non-small cell lung cancer that cannot be removed by surgery. The study will enroll 33 adults who have not had prior treatment. The goal is to see if the treatment can shrink tumors enough to allow surgery or improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iparomlimab and tuvonralimab (immune-boosting antibodies) plus paclitaxel polymer micelles and platinum chemotherapy (cisplatin or carboplatin)
- What this could lead to
- If successful, this combination could shrink or control advanced lung cancer tumors, potentially allowing more patients to become candidates for surgery.
- What could go wrong
- This is a small, early-phase trial with only 33 participants, so results may not apply broadly. The drug combination may cause significant side effects, and it is not yet known if it improves survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
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\. Males or females aged 18 to 75 years. * 2\. Histologically or cytologically confirmed squamous or non-squamous (EGFR/ALK/ROS1 negative) non-small cell lung cancer. * 3\. No prior local treatment (surgery or radiotherapy) or any systemic anti-tumor treatment for the tumor, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine treatment, or any other investigational drug treatment. * 4\. Patients with unresectable stage III disease (according to the 8th edition AJCC TNM staging for non-small cell lung cancer, T1-2N2-3M0, T3N1-3M0, T4N0-3M0) after multidisciplinary team (MDT) assessment. * 5\. At least one measurable lesion according to RECIST v1.1 criteria, as shown by chest enhanced CT or PET/CT. * 6\. ECOG performance status: 0 or 1. * 7\. The patient is able to tolerate induction therapy and surgery. Radical surgical resection and systematic lymph node dissection are recommended, provided that surgical margins can be ensured and the patient's general condition is taken into account. * 8\. Expected survival of ≥12 months. * 9\. Major organ and marrow function meet the following requirements: * Hematologic tests (no transfusions or blood products, no use of G-CSF or other hematopoietic growth factors within 14 days): 1. Hematologic indices: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. 2. Liver and kidney function indices: Total bilirubin ≤1.5×ULN, ALT/AST ≤2.5×ULN; creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min; urine routine test with proteinuria less than 2+. If the patient has proteinuria ≥2+ at baseline, a 24-hour urine collection should be performed to demonstrate that the 24-hour urine protein quantification is ≤1 g. 3. Coagulation function indices: INR ≤1.5; activated partial thromboplastin time (APTT) ≤1.5×ULN. 4. Endocrine system: Thyroid-stimulating hormone (TSH) within normal limits. Note: If TSH is not within the normal range at baseline, but T3 and free T4 are within the normal range, the subject is still eligible. * Cardiopulmonary function meets the following requirements: 1. Pulmonary function indices: FEV1.0 \> 1.0 L or FEV% \> 50%. 2. Cardiac function indices: Electrocardiogram (ECG) QTc interval \> 480 msec (QTc interval calculated using the Fridericia formula). * 10\. Women of childbearing potential must have used reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization. * 11\. The subject voluntarily agrees to participate in this study, signs the informed consent form, is compliant, and is willing to cooperate with follow-up. Exclusion Criteria: * 1\. Presence of contraindications to immunotherapy (including long-term use of corticosteroids, history of radiation pneumonitis, etc.). * 2\. History of severe allergy to paclitaxel, docetaxel, platinum agents, or their prophylactic medications. * 3\. Any unstable systemic disease, including active infection, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical therapy), unstable angina, angina attack within the past 3 months, liver disease requiring medication, kidney disease, or metabolic disease. * 4\. Received live vaccine within 28 days prior to treatment. * 5\. Previously received radiotherapy, chemotherapy, targeted therapy, or immunotherapy. * 6\. Active autoimmune disease (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.). * 7\. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc. * 8\. Active infection requiring antimicrobial treatment (e.g., requiring antibiotics, antiviral agents, antifungal agents). * 9\. Known history of allogeneic organ transplantation and known history of hematopoietic stem cell transplantation. * 10\. Patients with interstitial lung disease or a history of interstitial pneumonia. * 11\. History of drug abuse or mental disorders that cannot be controlled. * 12\. Previous or concurrent other untreated malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer. * 13\. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures. * 14\. Other situations that the investigator judges may affect the conduct of the clinical study or the determination of study results.
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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 Provincial Cancer Hospital
RECRUITINGNanjing, China
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