BridgeMD
Tests treatment safety and results for NSCLC
Official title A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07647094
What this study is testing
What is Serplulimab, Nab-Paclitaxel, Carboplatin?
Serplulimab, Nab-Paclitaxel, Carboplatin 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
- This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.
- Phase 1: an early, usually small safety study
- 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
- Sign a written informed consent before implementing any trial-related procedures;
- Age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th...
- Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously...
You likely can't join if
- Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy...
- Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma...
- Currently participating in an treatment clinical study treatment or received other study drugs or investigational devices within 4 weeks before the...
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T...
- Received Chinese patent medicines or immunomodulatory drugs with anti-NSCLC indications (including thymosin, interferon, interleukin, excluding local...
See the full eligibility criteria
- Sign a written informed consent before implementing any trial-related procedures;
- Age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the...
- Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously irradiated fields can be considered measurable if confirmed to have progressed;
- No prior systemic anti-tumor treatment for advanced/metastatic disease. people who previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be...
- people with asymptomatic or symptomatically stable brain metastases after local therapy are allowed to enroll if they meet the following conditions: measurable lesions outside the central nervous system; no central...
- Patients may receive palliative radiotherapy, but completion must be at least 7 days before the first dose of the study drug, and radiotherapy-related toxicities must recover to ≤ grade 1 (CTCAE 5.0);
- ECOG performance status 0-1;
- Expected survival \>3 months;
- Sufficient organ function: people must meet the following laboratory criteria: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L without using granulocyte colony-stimulating factor in the past 14 days; platelet count ≥100 ×...
- For female people of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days before the first study drug administration (Cycle 1, Day 1) and the result must be negative. If the urine...
- If there is a risk of pregnancy, all people (male or female) must use contraception methods with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last...
- Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy within 14 days before treatment; lung lesion radiotherapy with a dose...
- Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely...
- Currently participating in an treatment clinical study treatment or received other study drugs or investigational devices within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);
- Received Chinese patent medicines or immunomodulatory drugs with anti-NSCLC indications (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) for systemic treatment within 2...
- Experienced active autoimmune disease requiring systemic treatment (e.g., disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years before the first administration. Alternative therapies...
- Receiving systemic corticosteroid treatment (excluding nasal, inhaled, or other local corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration; Note: The...
- Presence of clinically uncontrollable pleural effusion/ascites (people who do not require drainage or whose effusion does not significantly increase after stopping drainage for 3 days may be enrolled);
- Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to the study drugs Serplulimab, Nab-Paclitaxel, carboplatin, or any of their excipients;
- Has not fully recovered from any toxicities and/or complications caused by prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the detection limit); Note: people with hepatitis B who meet the following criteria may also be enrolled: HBV viral load \<1000...
- people with active HCV infection (HCV antibody positive and HCV-RNA levels above the detection limit);
- Received a live vaccine within 30 days before first dosing (Cycle 1, Day 1); Note: Receiving injectable inactivated vaccines for seasonal influenza within 30 days prior to first dosing is allowed; however, intranasal...
- Pregnant or breastfeeding women;
- Presence of any serious or uncontrollable systemic disease, such as: significant and severe uncontrollable abnormalities in resting electrocardiogram in rhythm, conduction, or morphology, such as complete left bundle...
- History or evidence of disease, treatment or abnormal laboratory test values that may interfere with trial results or prevent the subject from participating in the study, or any other condition which the researcher...
The study team makes the final eligibility decision.
Where it's taking place
- Quzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Quzhou, Zhejiang, 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.