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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression
ClinicalTrials.gov ID: NCT06269211
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small-cell lung.
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
- The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression.
- 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
- Men and women aged ≥ 18 years old.
- Baseline tumor tissues have to be obtained through biopsy (percutaneous or transbronchial) or surgery at study center.
- Histologically confirmed diagnosis of primary non-small lung cancer on non-squamous histology.
- Pre-treatment stage as clinical II-IIIB (AJCC/UICC 8th Edition) (stage IIIB excludes N3 disease); curative resectability has to be explicitly...
- Confirmation by the central laboratory that the tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations.
You likely can't join if
- Patients with histologically confirmed squamous cell carcinoma, combined small cell carcinoma and large cell carcinoma.
- Molecular testing confirmed ALK translocation.
- Treatment with prior systemic cancer therapy for the current lung cancer at any time (chemotherapy, radiotherapy, target therapy, ablation, and any...
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial...
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. people with...
- people with a history of interstitial lung disease, pneumonitis, or poorly controlled lung disease (including pulmonary fibrosis, acute lung...
See the full eligibility criteria
- Men and women aged ≥ 18 years old.
- Baseline tumor tissues have to be obtained through biopsy (percutaneous or transbronchial) or surgery at study center.
- Histologically confirmed diagnosis of primary non-small lung cancer on non-squamous histology.
- Pre-treatment stage as clinical II-IIIB (AJCC/UICC 8th Edition) (stage IIIB excludes N3 disease); curative resectability has to be explicitly verified by the experienced surgical investigator.
- Confirmation by the central laboratory that the tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations.
- Have a PD-L1 tumor proportion score (TPS) ≥ 1% determined by IHC at the central laboratory. In order to balance patients with high PD-L1 expression (≥50%) and low PD-L1 expression (1-49%), we planned to enroll PD-L1...
- Have not received prior systemic treatment for NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Expected survival ≥ 3 months.
- Adequate blood and organ function.
- Patients with histologically confirmed squamous cell carcinoma, combined small cell carcinoma and large cell carcinoma.
- Molecular testing confirmed ALK translocation.
- Treatment with prior systemic cancer therapy for the current lung cancer at any time (chemotherapy, radiotherapy, target therapy, ablation, and any other local or systemic therapy).
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete...
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. people with vitiligo, type I diabetes mellitus, resolved childhood asthma/atopy...
- people with a history of interstitial lung disease, pneumonitis, or poorly controlled lung disease (including pulmonary fibrosis, acute lung diseases).
- Severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral treatment, including tuberculosis infections.
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL [2500 copies/mL] should be excluded.
- Has known active hepatitis C virus (HCV). Active HCV is defined by positive tests for HCV Ab and quantitative HCV RNA.
- Known positive history or positive test for Human Immunodeficiency Virus (HIV).
- The investigator believes that there is a high risk of bleeding (such as esophageal varices with bleeding risk, local active ulcer lesions) or active hemoptysis.
- History of allergy to study drug components.
- Pregnant and lactating women are excluded.
- Fertile men or their female partners (women of childbearing potential, WOCBP) who are not willing to use contraception.
- Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
- The investigator believes that there are factors that can increase medication risk or confuse outcome judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, 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 Guangzhou, Guangdong, China; Shanghai, Shanghai Municipality, 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.