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Unresectable Stage III Non-small Cell Lung CancerPhase 2NCT07408635

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

A Phase 2 study testing IBI363 + Chemotherapy in people with Unresectable Stage III Non-small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung Cancer (NSCLC), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IBI363 + Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
7 Jan 2026to 6 Jan 2030
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

  • The patient shall sign the informed consent.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.
  • Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours containing both NSCLC and small-cell lung cancer (SCLC) are excluded.
  • "Unresectable" is defined as following: (1) Multistation or confluent metastasis in ipsilateral mediastinal lymph nodes (2)Contralateral or supraclavicular lymph node metastasis (N3) (3)Invasion of critical organs or major blood vessels (4)Extensive invasion of the chest wall and pleura (5)Special anatomical locations (6）Patient intolerance to lobectomy or pneumonectomy.
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  • At least one measurable lesion per RECIST v1.1.
  • Adequate organ function meet the following standards (within 14 days before first dose, any blood components or growth factor drugs is not permitted):
  • ANC count ≥ 1.5 × 10⁹/L
  • Platelet count ≥ 100 × 10⁹/L
  • Hemoglobin ≥ 90 g/L
  • Serum Cr ≤ 1.5 times of upper limit of normal (ULN) or calculated creatinine clearance (CLcr) ≥ 50 mL/min
  • Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in Gilbert's syndrome)
  • AST and ALT ≤ 2.5 × ULN
  • INR or APPT ≤ 1.5 × ULN
  • left ventricular ejection fraction (LVEF) ≥ 50 %
  • Contraception and reproductive status:
  • Fertile female patients must voluntarily use effective contraception during the study period and for at least 3 months after treatment completion, and urine or serum pregnancy test result within 72 hours prior to enrollment are negative and must not be breastfeeding. Male patients with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose of IBI363.

Who cannot join

  • Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy.
  • History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator.
  • Histologically confirmed the presence of small cell lung cancer component.
  • Participants who have received any systemic anti-cancer treatment.
  • Clinically significant cardiovascular or cerebrovascular disease, including:
  • Myocardial infarction or unstable angina within 6 months before first dose
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  • Stroke or transient ischaemic attack within 6 months before first dose
  • Uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 100 mmHg) despite optimal therapy
  • Congestive heart failure (NYHA class III-IV)
  • Myocarditis
  • Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy are permitted.
  • Presence of any active autoimmune disease or history of autoimmune disease.
  • Idiopathic pulmonary fibrosis, organizing pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present.
  • History of allogeneic haematopoietic stem-cell or solid-organ transplantation.
  • The subject has congenital or acquired immune deficiency (such as HIV infected persons).
  • Active hepatitis (HBsAg positive and HBV DNA >the upper limit of normal value; HCV antibody and HCV RNA positive. Subjects who meet the following criteria may be enrolled: HBV-DNA <500 IU/mL measured within 28 days prior to study dosing, have received at least 4 weeks of standard antiviral therapy, and are willing to continue antiviral therapy throughout the study period.)
  • Participants who are allergic to the test drug or any auxiliary materials.
  • The vaccine was administered within 30 days before first dose or planned during treatment and up to 90 days after the last dose.
  • Severe active infection within 2 weeks before first dose.
  • Other factors that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.

Trial locations and contacts

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

Chang Chen, MD contact

+86 21 65115006

changchenc@hotmail.com

China1 site, 1 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai

    Chang Chen, MD, +86 21 65115006, changchenc@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

Read the detailed description

NSCLC patients receive IBI363 combined with platinum-based chemotherapy. If multidisciplinary team (MDT) assessment determines the patient is surgically eligible, surgery is performed followed by 1 year of standard adjuvant therapy. If, after 4 treatment cycles, MDT assessment determines the tumor remains unresectable, concurrent chemoradiotherapy followed by immune checkpoint inhibitor consolidation therapy is administered. This study aims to evaluate the efficacy of IBI363 combined with chemotherapy for neoadjuvant treatment of initially unresectable NSCLC based on R0 resection rate, major pathological response (MPR) rate, and pathological complete response (pCR) rate.

Being tested
IBI363 + Chemotherapy
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • IBI363 + ChemotherapyDrug

    1. Neoadjuvant treatment: IBI363 combined with platinum-based chemotherapy.
    2. Multidisciplinary team(MDT) assessment:

    Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year.

    If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.

Study groups in NCT07408635
Study groupRoleWhat they receive
IBI363 + ChemotherapyExperimental1. Neoadjuvant therapy phase: IBI363 combined with platinum-based chemotherapy. 2. Surgery phase: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.
Receives: Drug: IBI363 + Chemotherapy

What is being measured

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

  1. R0 Rate

    The proportion of subjects who underwent lung cancer resection and achieved complete resection (R0) among those receiving IBI363 combined chemotherapy conversion therapy.

    Measured: about 4 months after enrollment

Secondary outcomes (7)

  1. MPR Rate

    Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.

    Measured: about 5 months after enrollment

  2. pCR Rate

    Defined as the proportion of all patients who completed treatment and had no invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after surgery

    Measured: about 5 months after enrollment

  3. Tumor Downstaging Rate

    Defined as the proportion of patients whose imaging stage is downgraded through conversion therapy.

    Measured: up to 4 months

  4. Overall Response Rate (ORR)

    The proportion of patients who have had a complete response (CR) or partial response (PR) (according to RECIST1.1) after the neoadjuvant therapy.

    Measured: 12 weeks

  5. 2-Year EFS Rate

    The 2-year EFS rate is estimated using Kaplan-Meier survival analysis. The time from randomization to first occurrence of progression, disease recurrence (including local and distant recurrence), or death from any cause is assessed according to RECIST v1.1.

    Measured: up to 2 years

  6. 2-Year OS Rate

    The 2-year OS rate is estimated based on the Kaplan-Meier survival analysis. OS is defined as the time from enrollment to death due to any cause.

    Measured: up to 2 years

  7. Incidence of Treatment-related Adverse Events

    Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v6.0.

    Measured: From the subject's written consent to participate in the study through 30 days after the final administration of the drug

Timeline

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

  1. First posted13 Feb 2026
  2. Study start7 Jan 2026
  3. Primary completion6 Jun 2028 (estimated)
  4. Study completion6 Jan 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408635
Sponsor's protocol ID
STAR-017
Status last verified
Feb 2026
First submitted
22 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI363 + Chemotherapy in people with Unresectable Stage III Non-small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung Cancer (NSCLC), run by Shanghai Pulmonary Hospital, Shanghai, China 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 18 inclusion and 20 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 13 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 Chang Chen, MD (+86 21 65115006, changchenc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Rate (time frame: about 4 months after enrollment). 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 NCT07408635.

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 13 Feb 2026.

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