NSCLCPhase 2NCT07082179
A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) in people with NSCLC, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- 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 ≥2+ at baseline, a 24-hour urine collection should be performed to demonstrate that the 24-hour urine protein quantification is ≤1 g.
- 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 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.
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Cancer Hospital
Nanjing
Meiqi Shi, 13809029766, shimeiqi1963@163.com
About this study
Official title: The Efficacy and Safety of Iparomlimab and Tuvonralimab Combined With Paclitaxel Polymer Micelles and Platinum (Cisplatin/Carboplatin) in the Treatment of Stage III Unresectable Non-small Cell Lung Cancer
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. It aims to observe and evaluate the efficacy and safety of anti-PD-1/CTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.
Read the detailed description
This study includes a screening period (the maximum time interval from screening to the start of treatment ≤21 days), a treatment period (including the induction therapy phase, local therapy phase [surgery or radiotherapy], and consolidation therapy phase), and a follow-up period (including safety follow-up and survival follow-up). The primary endpoint is the objective response rate after induction therapy. Secondary endpoints include the pathological complete response rate in operable patients, major pathological response rate, surgical conversion rate, R0 resection rate, and 18-month event-free survival rate, among others.
- Conditions
- NSCLC
- Being tested
- Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)
- Keywords
- Iparomlimab and Tuvonralimab,Chemotherapy, unresectable non-small cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)Drug
The induction therapy regimen is as follows: Apalotamab: 5 mg/kg, every 3 weeks (q3w), administered via intravenous infusion. Paclitaxel polymer micelles in combination with platinum: In cycle 1, paclitaxel polymer micelles 230 mg/m² administered via intravenous infusion over ≥3 hours, with the option to escalate the dose in cycle 2 according to the instructions for use, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min. The local treatment regimen involves re-evaluation by a multidisciplinary team (MDT), surgery, or radical radiotherapy or single fractionated segmental radiotherapy (two radiotherapy regimens for the investigator to choose from). The consolidation therapy regimen consists of apalotamab consolidation for 1 year or up to a maximum of 17 cycles, with the decision to combine with chemotherapy left to the discretion of the treating physician on an individual basis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) Receives: Drug: Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate ,ORR
Measured: Approximately four months
Secondary outcomes (11)
Pathological complete remission rate, pCR
Measured: Approximately four months
Major pathological response rate , MPR
Measured: Approximately four months
Surgical conversion rate, SCR
Measured: Approximately four months
R0 resection rate
Measured: Approximately four months
18-month event-free survival rate
Measured: 18-month
Event Free Survival，EFS
Measured: up to 5 years after treatment discontinuation
Overall survival ,OS
Measured: up to 5 years after treatment discontinuation
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From ICF through 100 days after the last dose of study treatment
PD-L1 expression
Measured: Within 3 years
Tumor mutation burden (TMB)
Measured: Within 3 years
Next-generation sequencing (NGS), and chemotherapy drug sensitivity analysis
First, use NGS to identify the molecular characteristics of the tumor, and then infer or experimentally verify its sensitivity to specific chemotherapeutic drugs based on these characteristics, thereby achieving precision medicine in clinical practice or research.
Measured: Within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start4 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiqi Shi, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082179
- Sponsor's protocol ID
- Jiangsu Cancer Hospital
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Iparomlimab and Tuvonralimab Combined With Paclitaxel Polymer Micelles and Platinum (Cisplatin/Carboplatin) in the Treatment of Stage III Unresectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07082179
- Acronym / sponsor ID
- Jiangsu Cancer Hospital
- Conditions
- NSCLC
- Keywords
- Iparomlimab and Tuvonralimab,Chemotherapy, unresectable non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It aims to observe and evaluate the efficacy and safety of anti-PD-1/CTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.
Detailed description
This study includes a screening period (the maximum time interval from screening to the start of treatment ≤21 days), a treatment period (including the induction therapy phase, local therapy phase [surgery or radiotherapy], and consolidation therapy phase), and a follow-up period (including safety follow-up and survival follow-up). The primary endpoint is the objective response rate after induction therapy. Secondary endpoints include the pathological complete response rate in operable patients, major pathological response rate, surgical conversion rate, R0 resection rate, and 18-month event-free survival rate, among others.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)The induction therapy regimen is as follows: Apalotamab: 5 mg/kg, every 3 weeks (q3w), administered via intravenous infusion. Paclitaxel polymer micelles in combination with platinum: In cycle 1, paclitaxel polymer micelles 230 mg/m² administered via intravenous infusion over ≥3 hours, with the option to escalate the dose in cycle 2 according to the instructions for use, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min. The local treatment regimen involves re-evaluation by a multidisciplinary team (MDT), surgery, or radical radiotherapy or single fractionated segmental radiotherapy (two radiotherapy regimens for the investigator to choose from). The consolidation therapy regimen consists of apalotamab consolidation for 1 year or up to a maximum of 17 cycles, with the decision to combine with chemotherapy left to the discretion of the treating physician on an individual basis. | Drug | Experimental group |
Primary outcome
Objective response rate ,ORR
Time frame: Approximately four months
11 secondary outcomes
Pathological complete remission rate, pCR
Time frame: Approximately four months
Major pathological response rate , MPR
Time frame: Approximately four months
Surgical conversion rate, SCR
Time frame: Approximately four months
R0 resection rate
Time frame: Approximately four months
18-month event-free survival rate
Time frame: 18-month
Event Free Survival，EFS
Time frame: up to 5 years after treatment discontinuation
Overall survival ,OS
Time frame: up to 5 years after treatment discontinuation
Safety
Time frame: From ICF through 100 days after the last dose of study treatment
PD-L1 expression
Time frame: Within 3 years
Tumor mutation burden (TMB)
Time frame: Within 3 years
Next-generation sequencing (NGS), and chemotherapy drug sensitivity analysis
Time frame: Within 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin) in people with NSCLC, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meiqi Shi, Chief Physician (13809029766, shimeiqi1963@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate ,ORR (time frame: Approximately four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.