BridgeMD
New treatment option for NSCLC
Official title Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
ClinicalTrials.gov ID: NCT06714708
What this study is testing
What is Active comparator?
Active comparator is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc.
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
- To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III 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
- Patients who meet all of the following are eligible for inclusion in this study:
- Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.
- Age ≥ 18 years old.
- Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.
- According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM...
You likely can't join if
- 1\. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid...
- Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);
- Congestive heart failure [New York Heart Association (NYHA) classification ≥ II]; Serious arrhythmias, liver, kidney or metabolic diseases that...
- Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and/or fistula...
- people with hepatitis B who meet the following criteria meet the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load before...
See the full eligibility criteria
- Patients who meet all of the following are eligible for inclusion in this study:
- Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.
- Age ≥ 18 years old.
- Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.
- According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB...
- Non squamous NSCLC people need to undergo genetic testing to confirm the absence of EGFR sensitive mutations and ALK rearrangements. Squamous NSCLC people are not required to undergo genetic testing, but people with...
- Considered suitable for radical resection surgery.
- The lung function meets the criteria for planned lung resection (FEV1 ≥ 50% predicted value, MVV ≥ 50% predicted value), and there are no surgical contraindications.
- Can provide sufficient tissue specimens that meet the requirements for PD-L1 testing during the screening period. According to RECIST V1.1, there is at least one measurable lesion. 10. The Eastern Cooperative Oncology...
- Adequate liver function, defined as total bilirubin levels ≤ 1.5 × upper limit of normal (ULN) and levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin (ALB) ≥ 35g/L;
- Adequate renal function, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL/min (calculated using the Cockcroft/Gault formula), and urine routine test results showing urinary protein...
- 1\. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components. 2\. Tumors invade the diaphragm, mediastinum...
- Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);
- Congestive heart failure [New York Heart Association (NYHA) classification ≥ II]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;
- Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and/or fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic...
- people with hepatitis B who meet the following criteria meet the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load before randomization\<1000 copies/ml or\<200IU/ml or lower than the detection limit. HBsAg (+)...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 Hefei, Anhui, 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.