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.

NCT ID: NCT05487391

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 632 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2029-05-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

QL1706 plus Platinum-based chemotherapy

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

Group Type: EXPERIMENTAL

QL1706 injection

Intervention Type: DRUG

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

Vinorelbine Tartrate

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Pemetrexed

Intervention Type: DRUG

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

Placebo plus Platinum-based chemotherapy

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

Group Type: PLACEBO_COMPARATOR

Vinorelbine Tartrate

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Pemetrexed

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo

Interventions

QL1706 injection

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

Intervention Type: DRUG

Vinorelbine Tartrate

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caicun Zhou, MD, PhD

Role: STUDY_CHAIR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital, Shanghai. China

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiusong Qiu

Role: CONTACT

xiusong.qiu@qilu-pharma.com

86-13918736645

Facility Contacts

Caicun Zhou

Role: primary

References

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.

Reference Type: DERIVED

PMID: 37158938 (View on PubMed)

Other Identifiers

QL1706-304

Identifier Type: -

Identifier Source: org_study_id