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.

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Vinorelbine Tartrate; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: QL1706 injection; Drug: Cisplatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05487391

QL1706-304

Details and patient eligibility

About

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.

Enrollment: 632 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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632 participants in 2 patient groups, including a placebo group

QL1706 plus Platinum-based chemotherapy

Experimental group

Description:

QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy

Treatment:

Drug: Cisplatin

Drug: QL1706 injection

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Vinorelbine Tartrate

Placebo plus Platinum-based chemotherapy

Placebo Comparator group

Description:

Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy

Treatment:

Drug: Placebo

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Vinorelbine Tartrate