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New treatment option for Non-Small Cell Lung Cancer
Official title Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC
ClinicalTrials.gov ID: NCT06849167
What this study is testing
- What it's testing
- Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy.
- 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 to 70
You may be able to join if
- Sign a written informed consent before implementing any trial-related procedures.
- Age ≥ 18 years and ≤ 70 years, male or female.
- Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and...
- If EBUS/EUS or mediastinoscopy can safely obtain samples from the hilar or mediastinal lymph nodes, it is encouraged to obtain tissue for...
- Determined and documented by a multidisciplinary tumor board or consultation with a thoracic surgeon: the patient has inoperable stage IIB-IIIC NSCLC.
You likely can't join if
- but are unable to undergo thoracentesis due to minimal pleural effusion, they may still be included in the study.
- Provide a sufficient amount of quality-controlled tumor tissue or cell wax blocks for the pathology department of the study center to test PD-L1...
- At least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for use as a target lesion.
- No prior treatment for advanced/metastatic NSCLC (chemotherapy, targeted therapy, immunotherapy, or radiotherapy). Patients who have previously...
- Patients who have previously received induction immunotherapy can be included, including the following therapies: anti-PD-1, anti-PD-L1, or...
- ECOG performance status of 0-1.
See the full eligibility criteria
Who can join
- Sign a written informed consent before implementing any trial-related procedures.
- Age ≥ 18 years and ≤ 70 years, male or female.
- Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer 8th edition TNM lung cancer staging)...
- If EBUS/EUS or mediastinoscopy can safely obtain samples from the hilar or mediastinal lymph nodes, it is encouraged to obtain tissue for confirmation of involvement. When the lymph node boundary is clear and at least...
- Determined and documented by a multidisciplinary tumor board or consultation with a thoracic surgeon: the patient has inoperable stage IIB-IIIC NSCLC.
- No evidence of distant metastatic disease on diagnostic quality CT or MRI scans of the chest, abdomen, pelvis, and brain and/or whole-body fluorodeoxyglucose (FDG)-PET/CT, and classified as non-IV stage NSCLC (i.e...
What rules you out
- but are unable to undergo thoracentesis due to minimal pleural effusion, they may still be included in the study.
- Provide a sufficient amount of quality-controlled tumor tissue or cell wax blocks for the pathology department of the study center to test PD-L1 expression using the 22C3 antibody, with a PD-L1 TPS ≥ 20%; or a...
- At least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for use as a target lesion.
- No prior treatment for advanced/metastatic NSCLC (chemotherapy, targeted therapy, immunotherapy, or radiotherapy). Patients who have previously received systemic induction or neoadjuvant therapy (chemotherapy...
- Patients who have previously received induction immunotherapy can be included, including the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another co-stimulatory or inhibitory...
- ECOG performance status of 0-1.
- Life expectancy ≥ 6 months.
- Adequate organ function, with the following laboratory parameters:
- For women of childbearing potential, a negative urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test cannot be confirmed as...
- If there is a risk of pregnancy, all participants (regardless of sex) must use a contraceptive method with a failure rate of less than 1% during the entire treatment period and for 120 days after the last dose of the...
- Pathologically diagnosed small cell lung cancer (SCLC), or mixed tumors containing small cell components.
- Have undergone genetic testing prior to enrollment and known to have sensitive mutations in EGFR, ALK, or ROS-1 genes.
- people evaluated by the investigator with cavitary squamous carcinoma or imaging suggesting large vessel invasion/infiltration, or those with a history of active hemoptysis (coughing up at least 1/2 teaspoon of fresh...
- In the planned radiotherapy regimen, the volume of normal lung tissue (total lung - GTV) receiving a total radiation dose \>20Gy may exceed 34%. Have previously received any chest-directed radiotherapy (including...
- Have undergone major surgery within 3 weeks prior to the first dose of the study drug (excluding surgeries for biopsy purposes or vascular access placement, but people must have fully recovered from treatment toxicities...
- Have been diagnosed with a malignancy other than NSCLC within 5 years prior to the first dose (excluding surgically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or surgically resected...
- Are currently participating in an treatment clinical trial or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose, or are expected to require any other form...
- Have received traditional Chinese medicine with anti-lung cancer indications or immune-modulating drugs (including thymosin, interferons, interleukins) as systemic treatment within 2 weeks prior to the first dose of the...
- Have had active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of the study drug. Alternative therapies...
- Are receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of local glucocorticoid therapy) or any other form of immunosuppressive therapy within 7 days before the first dose of the study...
- Specific to pemetrexed: If aspirin or other NSAIDs cannot be discontinued for at least 2 days before, during, and 2 days after pemetrexed administration (except when daily aspirin dose is ≤1.3g), or the patient cannot...
- Have known history of organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
- Have known allergies to any of the active ingredients or excipients of the study drugs, including PD-1/PD-L1 monoclonal antibodies, pemetrexed, injectable albumin-bound paclitaxel, paclitaxel, carboplatin, cisplatin...
- Have a history of bleeding tendencies (e.g., active gastrointestinal ulcers) or are receiving anticoagulants or vitamin K antagonists such as warfarin, heparin, or its analogs. Note: Small-dose warfarin (≤1mg/day)...
- Have experienced severe arterial/venous thromboembolic events (e.g., cerebrovascular accident, including transient ischemic attacks, deep vein thrombosis, or pulmonary embolism) within 6 months prior to the first dose.
- Have not fully recovered from any toxicity and/or complications from previous interventions (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss).
- Have a known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive).
- Have untreated active hepatitis B (defined as HBsAg positive and HBV-DNA levels exceeding the upper normal limit at the local center's laboratory). Note: The following hepatitis B patients may be included: HBV viral...
- Have active HCV infection (HCV antibody positive with HCV-RNA levels above the detection threshold).
- Have received a live vaccine within 30 days prior to the first dose of the study drug (Day 1, Cycle 1). Note: Inactivated seasonal influenza vaccines and COVID-19 vaccines for prevention are allowed within 30 days prior...
- Are pregnant or breastfeeding women.
- Have any severe or uncontrolled systemic diseases
- Any other medical history or evidence of disease, treatment, or abnormal laboratory findings that may interfere with the study results or hinder participation, or any other conditions deemed unsuitable by the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.