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New treatment option for NSCLC
Official title A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07082179
What this study is testing
What is Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)?
Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, multicenter, open-label, single-arm Phase II clinical trial. The study recruits patients with stage III unresectable non-small cell lung cancer according to the 8th edition of the AJCC/UICC staging system.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- 5\. At least one measurable lesion according to RECIST v1.1 criteria, as shown by chest enhanced CT or PET/CT.
You likely can't join if
- 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...
- 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.).
See the full eligibility 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)...
- 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...
- 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):
- Hematologic indices: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L.
- 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...
- Coagulation function indices: INR ≤1.5; activated partial thromboplastin time (APTT) ≤1.5×ULN.
- 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:
- Pulmonary function indices: FEV1.0 \> 1.0 L or FEV% \> 50%.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.