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.

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05487391
• Other study ID #: QL1706-304
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: October 1, 2031

Study information

• Verified date: August 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Lianghua Fang
• Phone: 86-13645192882
• Email: lianghua.fang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 632
• Est. completion date: October 1, 2031
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 8 weeks after surgery (=56 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• QL1706 injection
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
• Vinorelbine Tartrate
Vinorelbine 25mg/m2(D1?D8)Q3W IV, 2-4 cycles
• Paclitaxel
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
• Cisplatin
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
• Carboplatin
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
• Pemetrexed
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.		Up to approximately 84 months
Secondary	Overall Survival (OS)	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.	Up to approximately 108 months
Secondary	Percentage of Participants Who are Survival at Year 4	OS rates will be measured in the PD-L1 subpopulation and in the ITT population.	Year 4
Secondary	Percentage of Participants Who are Disease-Free at Year 3	DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.	Year 3
Secondary	Percentage of Participants Who are Disease-Free at Year 5	DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.	Year 5
Secondary	DFS Within Selected Populations	Assessed by Investigator	Up to approximately 108 months
Secondary	Percentage of Participants with Adverse Events and Serious Adverse Events		Up to approximately 108 months