Combining QL1706 with chemotherapy for lung cancer treatment after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Pulmonary Hospital, Shanghai. China
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Xiusong Qiu
• Email: xiusong.qiu@qilu-pharma.com
• Phone: 86-13918736645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.