NCT05487391 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.
| NCT ID | NCT05487391 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 632 participants |
| Start Date | 2022-12-08 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 632 participants in total. It began in 2022-12-08 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Caicun Zhou, MD, PhD
STUDY CHAIR
Shanghai Pulmonary Hospital, Shanghai, China
Frequently Asked Questions
Who can join the NCT05487391 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05487391 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 632 participants.
Is NCT05487391 currently recruiting?
Yes, NCT05487391 is actively recruiting participants. Contact the research team at xiusong.qiu@qilu-pharma.com for enrollment information.
Where is the NCT05487391 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05487391 clinical trial?
NCT05487391 is sponsored by Qilu Pharmaceutical Co., Ltd.. The principal investigator is Caicun Zhou, MD, PhD at Shanghai Pulmonary Hospital, Shanghai, China. The trial plans to enroll 632 participants.