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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Pulmonary Hospital, Shanghai. China

Shanghai, China

Location status: Recruiting

Location contact

Caicun Zhou

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QL1706 injection

Drug

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

Vinorelbine Tartrate

Drug

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

paclitaxel

Drug

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

Cisplatin

Drug

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

carboplatin

Drug

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

Pemetrexed

Drug

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

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: Up to approximately 84 months

    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.

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

    Time frame: Up to approximately 84 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 108 months

    OS is defined as the time from random to death from any cause. OS will be measured in the PD-L1 subpopulation and in the ITT population.

  2. Percentage of Participants Who are Survival at Year 4

    Time frame: Year 4

    OS rates will be measured in the PD-L1 subpopulation and in the ITT population.

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

    Time frame: Year 3

    DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.

  4. Percentage of Participants Who are Disease-Free at Year 5

    Time frame: Year 5

    DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.

  5. DFS Within Selected Populations

    Time frame: Up to approximately 108 months

    Assessed by Investigator

  6. Percentage of Participants with Adverse Events and Serious Adverse Events

    Time frame: Up to approximately 108 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xiusong Qiu

CONTACT

[email protected]

86-13918736645

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Aug 4, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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