NCT05487391RecruitingPhase 3
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.
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.
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 632 (estimated)
- First submitted
- 1 Aug 2022
- Start date
- 8 Dec 2022
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT05487391
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 632
- From 8 Dec 2022 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Cardiovascular and cerebrovascular diseases with clinical significance.
- Gastrointestinal disease of clinical significance.
- Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
- Active uncontrolled hepatitis B or active hepatitis C.
Other
- Clinically significant lung damage.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital, Shanghai. China Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.