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New treatment option for Non-Small Cell Lung Cancer
Official title Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
ClinicalTrials.gov ID: NCT05800340
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, being studied as a potential treatment for 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
- Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.
- 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
- Age: 18 Years and older
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
- Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E...
- Lung function capacity capable of tolerating the proposed lung surgery
- Available tissue of tumor for PD-L1 test
You likely can't join if
- Stage I and stage IV NSCLC;
- Patients who have previously used any other anti-tumor drugs or radiotherapy;
- Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other driver mutations combined with MDM2/MDM4 amplification;
- Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- A history of active bleeding within the 6 months before enrollment, or receiving thrombolysis or anticoagulant therapy, or the investigator believes...
- Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease...
See the full eligibility criteria
- Age: 18 Years and older
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
- Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET...
- Lung function capacity capable of tolerating the proposed lung surgery
- Available tissue of tumor for PD-L1 test
- people voluntarily joined the study and signed informed consent, with good compliance to follow-up.
- Stage I and stage IV NSCLC;
- Patients who have previously used any other anti-tumor drugs or radiotherapy;
- Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other driver mutations combined with MDM2/MDM4 amplification;
- Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- A history of active bleeding within the 6 months before enrollment, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as...
- Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections; Clinically obvious gastrointestinal...
- Known or suspected autoimmune disease with activity. Participants may be enrolled if they have type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that require no systemic...
- Patients with active hepatitis B (positive for HBsAg) or hepatitis C (positive for HCV RNA).
- Patients with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Patients with other active malignancies within five years
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
- Patients with low compliance or willingness to take the drugs and surveillance.
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, 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 Guanzhou, Guangdong, 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.