Non-Small Cell Lung CancerPhase 2NCT06528847
Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma
A Phase 2 study testing Benmelstobart in people with Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Benmelstobart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2024to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Haoran E, MD, +86-021-65115006, ehr@tongji.edu.cn
Deping Zhao, MD, PhD, +86-021-65115006, dpzhao@tongji.edu.cn
About this study
Official title: Benmelstobart (TQB2450) for Adjuvant Therapy in Pathologic Stage IB, IASLC Grade 3 Invasive Lung Adenocarcinomas: A Prospective, Single-arm, Phase 2 Clinical Trial
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Benmelstobart
- Keywords
- Immunotherapy, Adjuvant therapy, Lung adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenmelstobartDrug
Also called TQB2450
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Benmelstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 year
Secondary outcomes (4)
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.
Measured: up to 3 year
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.
Measured: up to 5 year
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.
Measured: up to 5 year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start5 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, interventional, single-arm, phase 2 clinical trial.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Deping Zhao, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaChang Chen, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528847
- Sponsor's protocol ID
- STAR010
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38992123Xue 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 38188467Han 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benmelstobart (TQB2450) for Adjuvant Therapy in Pathologic Stage IB, IASLC Grade 3 Invasive Lung Adenocarcinomas: A Prospective, Single-arm, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06528847
- Acronym / sponsor ID
- STAR010
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Immunotherapy, Adjuvant therapy, Lung adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, interventional, single-arm, phase 2 clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Benmelstobart Group | Experimental | Drug: BenmelstobartEnrolled 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenmelstobartAlso: TQB2450The 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. | Drug | Adjuvant Benmelstobart Group |
Primary outcome
disease-free survival (DFS) rate
Time frame: up to 2 year
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.
4 secondary outcomes
disease-free survival (DFS) rate
Time frame: up to 3 year
disease-free survival (DFS) rate
Time frame: up to 5 year
overall survival (OS) rate
Time frame: up to 5 year
drug safety
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 38992123Cheng 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.
- Background: PubMed 38188467Xue 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.
- Background: PubMed 37973901Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deping Zhao, MD, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Chang Chen, MD, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benmelstobart in people with Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haoran E, MD (+86-021-65115006, ehr@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) rate (time frame: up to 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.