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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.
ClinicalTrials.gov ID: NCT05487391
What this study is testing
What is QL1706 injection?
QL1706 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small-cell lung.
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
- The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- people voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
- Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
- Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0)...
- Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
- Non-squamous NSCLC people without EGFR-sensitizing mutation or ALK fusion gene.
You likely can't join if
- Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an...
- Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
- Cardiovascular and cerebrovascular diseases with clinical significance.
- Gastrointestinal disease of clinical significance.
- Clinically significant lung damage.
- Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
See the full eligibility criteria
- people voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
- Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
- Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
- Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
- Non-squamous NSCLC people without EGFR-sensitizing mutation or ALK fusion gene.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- people (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.
- Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study...
- Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
- Cardiovascular and cerebrovascular diseases with clinical significance.
- Gastrointestinal disease of clinical significance.
- Clinically significant lung damage.
- Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
- Active uncontrolled hepatitis B or active hepatitis C.
- Administer a live vaccine within 30 days prior to the first dose of study treatment.
- Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in...
- Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin...
- History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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, 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.