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Carcinoma, Non-Small-Cell LungPhase 2NCT07129161

Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

A Phase 2 study testing 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy) and 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy) in people with Carcinoma, Non-Small-Cell Lung, run by Sun Yat-sen University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy) and 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesChina
Study dates
Aug 2025to Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 9th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
  • MDT assessment (including a thoracic surgeon) confirms resectability.
  • Provision of tumor tissue for biomarker analysis (e.g., PD-L1 testing, gene sequencing).
  • At least one measurable lesion per RECIST v1.1.
  • ECOG performance status 0 or 1.

Who cannot join

  • Confirmed EGFR or ALK mutations.
  • Other malignancies within 5 years (exceptions: adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical surgery, ductal carcinoma in situ post-radical surgery).
  • Prior treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors, CTLA-4 inhibitors) or immunostimulatory antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or anti-tumor immune cell therapy.
  • Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) within 2 weeks prior to enrollment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Junye Wang contact

13719229662

wangjy@sysucc.org.cn

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Junye Wang

    Junye Wang

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an

Other trials in China

About this study

This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC.

Being tested
4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy), 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy)Drug

    Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w

  • 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)Drug

    Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w

Study groups in NCT07129161
Study groupRoleWhat they receive
Iparomlimab and Tuvonralimab combined with 2 cycles of chemotherapy as neoadjuvant therapyExperimentalIparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 2 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion.
Receives: Drug: 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy)
Iparomlimab and Tuvonralimab combined with 4 cycles of chemotherapy as neoadjuvant therapyExperimentalIparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 4 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion.
Receives: Drug: 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response (pCR) Rate

    Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of viable tumor cells in the resected lung tumor bed and lymph nodes.

    Measured: One week postoperatively

Secondary outcomes (6)

  1. Major Pathologic Response (MPR) Rate

    Major pathologic response (MPR) rate is defined as percentage of participants with ≤10% viable tumor cells in the resected lung tumor bed and lymph nodes.

    Measured: One week postoperatively

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the percentage of participants with a best response of complete response (CR) or partial response (PR) on preoperative imaging among all subjects who received neoadjuvant therapy and had at least one post-baseline imaging assessment.

    Measured: Prior to surgery

  3. R0 Resection rate

    R0 Resection rate is defined as the percentage of participants who achieve complete surgical resection (R0).

    Measured: At time of surgery

  4. 2-Year Event-Free Survival (EFS) Rate

    EFS is defined as the time from the first study treatment to the occurrence of any event, including disease progression or deterioration preventing surgery, inability to achieve gross resection, disease recurrence, or death from any cause. The 2-year EFS rate was estimated using the Kaplan-Meier method.

    Measured: up to 2 years

  5. Disease-free survival (DFS)

    Disease-free survival (DFS) is the length of time from postoperative baseline imaging confirmation of no residual disease to disease recurrence or death from any cause, whichever occurs first.

    Measured: up to 3 years

  6. Overall Survival (OS)

    Overall Survival (OS) is the length of time after initial administration the participant remains alive.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07129161
Sponsor's protocol ID
QL-NSCLC-QIBA-1003
Status last verified
Aug 2025
First submitted
24 Jul 2025
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy) and 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy) in people with Carcinoma, Non-Small-Cell Lung, run by Sun Yat-sen University at 2 sites 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Junye Wang (13719229662, wangjy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) Rate (time frame: One week postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07129161.

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 19 Aug 2025.

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