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New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC
ClinicalTrials.gov ID: NCT07330596
What this study is testing
What is QL1706 combined with Chemotherapy?
QL1706 combined with Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
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
- Lung cancer is the leading cause of cancer-related deaths worldwide. According to the 2023 global cancer statistics, there are approximately 2.47 million new cases and 1.76 million deaths of lung cancer annually, accounting for 18.4% of all cancer deaths.
- Phase 2: a mid-size study of how well it works
- 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
- Voluntarily participate in the research and sign an informed consent form; Age ≥ 18 years old, ≤ 75 years old;
- Diagnosed with NSCLC through histology or cytology;
- No EGFR sensitive mutations or ALK gene translocation changes;
- Previously received PD-1/PD-L1 inhibitors combined with platinum based dual therapy or sequential therapy as first-line treatment for advanced...
- ECOG score: 0-2 points;
You likely can't join if
- There are EGFR sensitive mutations or ALK gene translocation changes present;
- Previously received PD1/CTLA4 bispecific antibody therapy;
- Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) grade 1 or below (excluding toxicity ≤ grade 2 that has been...
- Symptomatic central nervous system metastasis. Patients who have received treatment for brain metastases and have been deemed stable by researchers...
- For patients with poor control of cancer-related pain, those who require analgesic treatment must receive a stable dose of treatment before...
- Chest fluid, ascites or pericardial effusion with clinical symptoms or unstable condition after symptomatic treatment;
See the full eligibility criteria
- Voluntarily participate in the research and sign an informed consent form; Age ≥ 18 years old, ≤ 75 years old;
- Diagnosed with NSCLC through histology or cytology;
- No EGFR sensitive mutations or ALK gene translocation changes;
- Previously received PD-1/PD-L1 inhibitors combined with platinum based dual therapy or sequential therapy as first-line treatment for advanced metastatic or recurrent NSCLC, and disease progression occurred during or...
- ECOG score: 0-2 points;
- Expected survival period is not less than 12 weeks;
- Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 28 days before enrollment, and voluntarily use appropriate contraception methods during the observation period and...
- The laboratory test results during the screening period indicate that the patient has good organ function: a) Hematology (no blood transfusion within 14 days and no treatment with blood components or granulocyte...
- Patients whom researchers believe can benefit.
- There are EGFR sensitive mutations or ALK gene translocation changes present;
- Previously received PD1/CTLA4 bispecific antibody therapy;
- Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) grade 1 or below (excluding toxicity ≤ grade 2 that has been determined by the researcher to exist for a long time, cannot be...
- Symptomatic central nervous system metastasis. Patients who have received treatment for brain metastases and have been deemed stable by researchers may consider participating in this study;
- For patients with poor control of cancer-related pain, those who require analgesic treatment must receive a stable dose of treatment before participating in the study;
- Chest fluid, ascites or pericardial effusion with clinical symptoms or unstable condition after symptomatic treatment;
- Known to have a history of severe allergic reactions to the drug and its components, planned chemotherapy drugs, and those with a history of severe allergic reactions;
- Suffering from or suspected of active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory intestinal diseases, etc., except: type I diabetes and...
- History of interstitial lung disease or drug-induced interstitial lung disease or pneumonia in the past;
- Corticosteroid drugs (prednisone\>10mg/day or equivalent dose) or other immunosuppressive drugs received systemically within 14 days prior to the first study medication;
- Individuals with a history of immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, those with a history of organ transplantation, or those who have received allogeneic...
- Suffering from serious cardiovascular and cerebrovascular diseases: a) poorly controlled hypertension or pulmonary arterial hypertension; b) Unstable angina or myocardial infarction, coronary artery bypass grafting or...
- Positive result of human immunodeficiency virus (HIV) antibody test, active hepatitis B or C. The following conditions are allowed to participate in this study: a) hepatitis B core antibody (HBcAb) or hepatitis B...
- Suffering from other active malignant tumors other than the research disease within 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to fully treated...
- Individuals with a history of substance abuse and inability to quit, or those with a history of mental disorders;
- Pregnant or lactating women;
- The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, 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.