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.

NCT05487391 | Recruiting Phase 3 DMC

• 1 other identifier: QL1706-304
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.

  DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis.

  Up to approximately 84 months

• Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.

  Up to approximately 84 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to approximately 108 months

• Percentage of Participants Who are Survival at Year 4

  Year 4

• Percentage of Participants Who are Disease-Free at Year 3

  Year 3

• Percentage of Participants Who are Disease-Free at Year 5

  Year 5

• DFS Within Selected Populations

  Up to approximately 108 months

Study Arms (2)

QL1706 plus Platinum-based chemotherapy

EXPERIMENTAL

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

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

Placebo plus Platinum-based chemotherapy

PLACEBO COMPARATOR

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

Drug: Vinorelbine Tartrate; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Placebo

Interventions

QL1706 injection DRUG

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

QL1706 plus Platinum-based chemotherapy

Vinorelbine Tartrate DRUG

Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles

Placebo plus Platinum-based chemotherapy; QL1706 plus Platinum-based chemotherapy

Paclitaxel DRUG

Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles

Placebo plus Platinum-based chemotherapy; QL1706 plus Platinum-based chemotherapy

Cisplatin DRUG

Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles

Placebo plus Platinum-based chemotherapy; QL1706 plus Platinum-based chemotherapy

Carboplatin DRUG

Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles

Placebo plus Platinum-based chemotherapy; QL1706 plus Platinum-based chemotherapy

Pemetrexed DRUG

Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles

Placebo plus Platinum-based chemotherapy; QL1706 plus Platinum-based chemotherapy

Placebo DRUG

Placebo

Placebo plus Platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital, Shanghai. China

Shanghai, China

RECRUITING

Related Publications (1)

• Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

  PMID: 37158938 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Paclitaxel; Cisplatin; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Caicun Zhou, MD, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Xiusong Qiu

CONTACT

86-13918736645; xiusong.qiu@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 4, 2022
• Study Start: December 8, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): May 22, 2029
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)