Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma

NCT06528847 | Recruiting Phase 2 DMC

• 1 other identifier: STAR010
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, phase 2 clinical trial assessing the feasibility, efficacy, and safety of the PD-L1 inhibitor Benmelstobart (TQB2450) as an adjuvant therapy regimen in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement.

Conditions

Non-Small Cell Lung Cancer

Keywords

Immunotherapy; Adjuvant therapy; Lung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS) rate

  The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first.

  up to 2 year

Secondary Outcomes (4)

• disease-free survival (DFS) rate

  up to 3 year

• disease-free survival (DFS) rate

  up to 5 year

• overall survival (OS) rate

  up to 5 year

• drug safety

  up to 1 year

Study Arms (1)

Adjuvant Benmelstobart Group

EXPERIMENTAL

Enrolled patients will receive adjuvant immunotherapy with the PD-L1 inhibitor Benmelstobart (TQB2450) at a dose of 1200 mg every 3 weeks by intravenous injection, for a maximum of 16 cycles following radical resection.

Drug: Benmelstobart

Interventions

Benmelstobart DRUG

The PD-L1 inhibitor Benmelstobart (TQB2450) is administered as an adjuvant therapy in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma who do not have EGFR active mutations or ALK rearrangement.

Also known as: TQB2450

Adjuvant Benmelstobart Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are able to understand the informed consent form, voluntarily agree to participate, and sign the informed consent form;
• Participants must be 18 years or older and under 75 years of age on the day they sign the informed consent form;
• Pathologically confirmed stage IB (AJCC TNM staging, 8th edition) lung adenocarcinoma;
• Achieved complete resection (R0) after lobectomy, bilobectomy, or sleeve resection;
• Pathologically diagnosed as grade 3 invasive lung adenocarcinoma according to the 2020 grading system proposed by the International Association for the Study of Lung Cancer (IASLC) Pathology Committee (poorly differentiated: any tumor with 20% or more of high-grade patterns, including solid, micropapillary, and/or complex glandular patterns);
• No prior receipt of any anti-tumor treatment, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy;
• Expected survival time more than 12 weeks;
• No active EGFR mutations (including but not limited to exon 19 deletions, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutations) or ALK rearrangements;
• Tumor PD-L1 expression ≥1% (the PD-L1 IHC 22C3 pharmDx reagent, antibody clone number: 22C3, detection platform: DAKO Autostainer Link 48);
• Patients are screened and enrolled within 4 to 12 weeks after surgery;
• Performance status score of 0 or 1 (Eastern Cooperative Oncology Group (ECOG) performance status scale);
• For female participants of childbearing potential, a negative serum pregnancy test must be obtained within 7 days prior to the first dose of the study drug;
• Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use highly effective contraception (with an annual failure rate of less than 1%) starting from 7 days before the first dose of the study drug and continuing until 24 weeks after the last dose;
• Major organ functions must be normal within 7 days prior to the first dose of the study drug.

You may not qualify if:

• Postoperative pathological diagnosis of mixed histological features;
• Incomplete resection (R1/R2) or wedge resection, segmentectomy;
• Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose of the study drug;
• Systemic corticosteroids or immunosuppressants must have been administered continuously for 7 days within 14 days prior to the first dose of the study drug;
• Received live vaccines (including attenuated live vaccines) within 28 days prior to the study drug administration;
• History of or currently having interstitial lung disease/condition requiring systemic corticosteroid treatment;
• History of or currently having autoimmune disease;
• Presence of other malignant tumors within 5 years prior to the first dose of the study drug;
• Presence of uncontrolled comorbidities such as cardiac, renal, gastrointestinal, or infectious diseases;
• History of allogeneic bone marrow or organ transplantation;
• History of using any antibodies or drugs targeting T-cell co-regulatory proteins (immune checkpoints), or previous treatment with anti-tumor vaccines;
• History of hypersensitivity or intolerance to antibody-based drugs, history of any rapid allergic reactions, uncontrolled asthma, or significant drug allergies;
• Pregnant and/or breastfeeding women;
• Other conditions that may affect the safety or compliance of the study drug, including but not limited to psychiatric disorders, uncontrolled large pleural effusions, or moderate to large pleural effusions requiring repeated drainage.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (3)

• Cheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, Huang C, Wei S, Sun H, Li X, Yu Y, Lai J, Yang H, Fang H, Chen H, Zhang P, Gu K, Wang Q, Shi J, Yi T, Xu X, Ye X, Wang D, Xie C, Liu C, Zheng Y, Lin D, Zhuang W, Lu P, Yu G, Li J, Gu Y, Li B, Wu R, Jiang O, Wang Z, Wu G, Lin H, Zhong D, Xu Y, Shu Y, Wu D, Chen X, Wang J, Wang M, Yang R. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30(10):2967-2976. doi: 10.1038/s41591-024-03132-1. Epub 2024 Jul 11.

  PMID: 38992123 BACKGROUND

• Xue J, Xue L, Tang W, Ge X, Zhao W, Li Q, Peng W, Dai C, Guo Y, Li J. TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Ther Adv Med Oncol. 2024 Jan 6;16:17588359231220516. doi: 10.1177/17588359231220516. eCollection 2024.

  PMID: 38188467 BACKGROUND

• Han Y, Wang J, Sun T, Ouyang Q, Li J, Yuan J, Xu B. Predictive biomarkers of response and survival following immunotherapy with a PD-L1 inhibitor benmelstobart (TQB2450) and antiangiogenic therapy with a VEGFR inhibitor anlotinib for pretreated advanced triple negative breast cancer. Signal Transduct Target Ther. 2023 Nov 17;8(1):429. doi: 10.1038/s41392-023-01672-5.

  PMID: 37973901 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Deping Zhao, MD, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Chang Chen, MD, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoran E, MD

CONTACT

+86-021-65115006; ehr@tongji.edu.cn

Deping Zhao, MD, PhD

CONTACT

+86-021-65115006; dpzhao@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Deputy Head of Thoracic Surgery Dept.

Model Details: This study is a prospective, interventional, single-arm, phase 2 clinical trial.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)