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New treatment option for Lung Cancer Non-Small Cell Cancer (NSCLC)
Official title EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC
ClinicalTrials.gov ID: NCT07637448
What this study is testing
What is EGFR-TKIs Combined with PD-1 Monoclonal Antibody?
EGFR-TKIs Combined with PD-1 Monoclonal Antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer non-small cell cancer (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 an open-label, multicenter, single-arm clinical study.
- 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 with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage...
- Male or female patients aged ≥ 18 years;
- Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;
You likely can't join if
- Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;
- Prior treatment with anti-PD-1/PD-L1 immunotherapy;
- Concurrent enrollment in another clinical study;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Receipt of systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose of study drug;
- Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or planned receipt of live vaccine during the study period;
See the full eligibility criteria
- Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th...
- Male or female patients aged ≥ 18 years;
- Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;
- Adequate organ function;
- Female or male patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study period;
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements as specified in the visit schedule.
- Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;
- Prior treatment with anti-PD-1/PD-L1 immunotherapy;
- Concurrent enrollment in another clinical study;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Receipt of systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose of study drug;
- Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or planned receipt of live vaccine during the study period;
- Presence of brainstem, leptomeningeal, spinal cord metastasis, or spinal cord compression;
- Presence of uncontrolled concomitant diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, etc.;
- History of severe gastrointestinal ulcer, gastrointestinal perforation, fistula or obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose, or other...
- Presence of severe uncontrolled cardiovascular disease;
- Interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) requiring corticosteroid therapy, or current ILD/non-infectious pneumonitis;
- Concomitant pulmonary disease resulting in clinically severe impairment of respiratory function;
- Chronic autoimmune disease or inflammatory disease requiring systemic therapy or receiving systemic therapy within 2 years prior to the first dose;
- Active or history of documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), intestinal obstruction, or extensive bowel resection;
- Diagnosis of Gilbert's syndrome;
- Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
- Known active pulmonary tuberculosis;
- Known active syphilis infection;
- Known history of immunodeficiency, or positive test for human immunodeficiency virus (HIV) antibody;
- Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- Known allergy to any component of any study drug, history of severe allergic reactions (e.g., anaphylactic shock), history of severe hypersensitivity to other monoclonal antibodies or recombinant protein-based...
- Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period;
- Any disease, medical condition, organ system dysfunction, or social circumstance (including but not limited to psychiatric illness, substance/alcohol abuse, history of drug abuse, etc.) that, in the investigator's...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.