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Tests treatment safety and results for Non-Small Cell Lung Carcinoma (NSCLC)
Official title A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT07362459
What this study is testing
What is SCTB14?
SCTB14 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung carcinoma (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 Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival.
- Phase 3: a large, late-stage 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 and older
You may be able to join if
- Voluntarily sign the written informed consent form prior to screening.
- Age ≥ 18 years, both male and female.
- ECOG Performance Status score of 0 to 1.
- An expected survival of ≥ 3 months.
- Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer...
You likely can't join if
- Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
- Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine...
- Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
- Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
- people with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain...
- Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of...
See the full eligibility criteria
Who can join
- Voluntarily sign the written informed consent form prior to screening.
- Age ≥ 18 years, both male and female.
- ECOG Performance Status score of 0 to 1.
- An expected survival of ≥ 3 months.
- Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical...
- For people with non-squamous cell carcinoma, as well as non-smoking people with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene...
- people must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.
- No prior systemic anti-tumor therapy for the studied disease.
- At least one measurable non-CNS lesion according to RECIST v1.1 criteria.
- Adequate function of major organs.
What rules you out
- Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
- Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
- Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
- Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
- people with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
- Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
- Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
- History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
- A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
- A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.
- The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
- A history of esophageal/gastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and/or fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive...
- A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
- The presence of other malignant tumors.
- Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.
- Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.
- Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV...
- Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
- Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
- A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
- Current participation in another clinical trial, with the exception of observational (non-treatment) studies or the follow-up phase of an treatment trial.
- Pregnancy or lactation in female people.
- A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
- Tumor-induced conditions or symptoms associated with a high medical risk.
- Any other condition deemed by the investigator to be inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.