Combining QL1706 with chemotherapy for lung cancer treatment after surgery
QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.
This study is testing if adding a new treatment called QL1706 to standard chemotherapy helps people with stage II-IIIB lung cancer feel better after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 632 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05487391 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of QL1706 when combined with platinum-based chemotherapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) who have undergone complete surgical resection. Participants will be randomly assigned to receive either the QL1706 treatment or a placebo alongside standard chemotherapy. The study aims to determine if the addition of QL1706 improves outcomes compared to chemotherapy alone. Approximately 316 subjects will be involved in this Phase 3 trial.
Who should consider this trial
Good fit: Ideal candidates are adults with stage II-IIIB non-small cell lung cancer who have had complete surgical resection and do not have EGFR-sensitizing mutations or ALK fusions.
Not a fit: Patients currently participating in other investigational drug studies or those with EGFR mutations or ALK fusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with advanced lung cancer after surgery.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in lung cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects 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 subjects without EGFR-sensitizing mutation or ALK fusion gene. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects (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. Exclusion Criteria: * 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 treatment. * 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 situ.) * 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, carboplatin) or their preventive drugs, etc. * History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.
Where this trial is running
Shanghai
- Shanghai Pulmonary Hospital, Shanghai. China — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xiusong Qiu
- Email: xiusong.qiu@qilu-pharma.com
- Phone: 86-13918736645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.