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New treatment option for Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Official title IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07122687
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for resectable stage ib-iii non-squamous 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 randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Males and Females, age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed primary non-squamous NSCLC:
- Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
- No administration of any anti-NSCLC therapy in the pre-operative period;
- Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
You likely can't join if
- Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor...
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
- Pancoast tumor;
- Malignant tumor nodule in the contralateral lung lobe;
- Participants with known or suspected brain metastases or other distant metastases;
- Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2...
See the full eligibility criteria
- Males and Females, age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed primary non-squamous NSCLC:
- Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
- No administration of any anti-NSCLC therapy in the pre-operative period;
- Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
- Participants without EGFR mutations or ALK translocation;
- At least 1 measurable lesion per RECISIT v1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Adequate organ function confirmed at screening period.
- Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma...
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
- Pancoast tumor;
- Malignant tumor nodule in the contralateral lung lobe;
- Participants with known or suspected brain metastases or other distant metastases;
- Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
- Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
- History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
- History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
- History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
- Active or uncontrolled diseases or conditions;
- History of immunodeficiency disease;
- Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, 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 Shenyang, Liaoning, 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.