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New treatment option for Unresectable Stage III Non-small Cell Lung Cancer
Official title IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07408635
What this study is testing
What is IBI363 + Chemotherapy?
IBI363 + Chemotherapy is an investigational medicine, being studied as a potential treatment for unresectable stage iii non-small cell lung cancer.
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 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.
- 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 and older
You may be able to join if
- 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...
- Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- 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...
- 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. people who meet the following criteria may be enrolled: HBV-DNA \<500 IU/mL measured within 28 days...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.