ClinicalTrials.gg
RecruitingNCT06528847Updated Jul 31, 2024

Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma

A Phase 2 interventional study of Benmelstobart in Non-Small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

The target population for this study includes patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement who have undergone radical resection at Shanghai Pulmonary Hospital. Patients are screened and enrolled within 4 to 12 weeks after surgery. Following surgery, adjuvant chemotherapy may be administered based on the patient's treatment needs or the attending physician's assessment. Subsequently, patients will receive adjuvant immunotherapy with the PD-L1 inhibitor Benmelstobart (TQB2450 injection) at a dose of 1200 mg every 3 weeks by intravenous injection, for a maximum of 16 cycles. The primary endpoint is the 2-year disease-free survival (DFS) rate. The secondary endpoints include the 3-year and 5-year DFS rates, the 5-year overall survival (OS) rate, and drug safety. The sample size is 62 patients.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Immunotherapy
  • Adjuvant therapy
  • Lung adenocarcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 62 is close to the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants are able to understand the informed consent form, voluntarily agree to participate, and sign the informed consent form;
  2. Participants must be 18 years or older and under 75 years of age on the day they sign the informed consent form;
  3. Pathologically confirmed stage IB (AJCC TNM staging, 8th edition) lung adenocarcinoma;
  4. Achieved complete resection (R0) after lobectomy, bilobectomy, or sleeve resection;
  5. 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);
  6. No prior receipt of any anti-tumor treatment, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy;
  7. Expected survival time more than 12 weeks;
  8. 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;
  9. Tumor PD-L1 expression ≥1% (the PD-L1 IHC 22C3 pharmDx reagent, antibody clone number: 22C3, detection platform: DAKO Autostainer Link 48);
  10. Patients are screened and enrolled within 4 to 12 weeks after surgery;
  11. Performance status score of 0 or 1 (Eastern Cooperative Oncology Group (ECOG) performance status scale);
  12. 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;
  13. 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;
  14. Major organ functions must be normal within 7 days prior to the first dose of the study drug.

Exclusion criteria

Exclusion Criteria:

  1. Postoperative pathological diagnosis of mixed histological features;
  2. Incomplete resection (R1/R2) or wedge resection, segmentectomy;
  3. 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;
  4. Systemic corticosteroids or immunosuppressants must have been administered continuously for 7 days within 14 days prior to the first dose of the study drug;
  5. Received live vaccines (including attenuated live vaccines) within 28 days prior to the study drug administration;
  6. History of or currently having interstitial lung disease/condition requiring systemic corticosteroid treatment;
  7. History of or currently having autoimmune disease;
  8. Presence of other malignant tumors within 5 years prior to the first dose of the study drug;
  9. Presence of uncontrolled comorbidities such as cardiac, renal, gastrointestinal, or infectious diseases;
  10. History of allogeneic bone marrow or organ transplantation;
  11. History of using any antibodies or drugs targeting T-cell co-regulatory proteins (immune checkpoints), or previous treatment with anti-tumor vaccines;
  12. History of hypersensitivity or intolerance to antibody-based drugs, history of any rapid allergic reactions, uncontrolled asthma, or significant drug allergies;
  13. Pregnant and/or breastfeeding women;
  14. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Adjuvant Benmelstobart Group

    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

  • 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

06

What researchers measure

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.

    Time frame: up to 2 year

Secondary 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.

    Time frame: up to 3 year

  2. 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.

    Time frame: up to 5 year

  3. overall survival (OS) rate

    The overall survival (OS) is defined as the time from surgery to death from any cause or the end of the study, whichever comes first.

    Time frame: up to 5 year

  4. drug safety

    The frequency of severe adverse events will be measured from participant enrollment to 30 days after the last drug administration or the initiation of new anti-cancer therapy, whichever comes first.

    Time frame: up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
    • Haoran E, MD · Contact · ehr@tongji.edu.cn · +86-021-65115006
    • Deping Zhao, MD, PhD · Contact · dpzhao@tongji.edu.cn · +86-021-65115006
    • Deping Zhao, MD, PhD · Principal investigator
    • Chang Chen, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 38992123 ↗
  • 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. PubMed 38188467 ↗
  • 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. PubMed 37973901 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.

Of 678 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 81. This study's planned 36 months is below that.

Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2024
First posted
Jul 30, 2024
StartActual
Jun 5, 2024
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2030
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06528847
Responsible party
Deping Zhao (Chief Physician, Deputy Head of Thoracic Surgery Dept., Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Jul 30, 2024
Start date
Jun 5, 2024
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jul 31, 2024

Study contacts

Haoran E, MD
Contact
ehr@tongji.edu.cn
+86-021-65115006
Deping Zhao, MD, PhD
Contact
dpzhao@tongji.edu.cn
+86-021-65115006
Deping Zhao, MD, PhD
principal investigator · Shanghai Pulmonary Hospital, Shanghai, China
Chang Chen, MD, PhD
principal investigator · Shanghai Pulmonary Hospital, Shanghai, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Benmelstobart

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