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New treatment option for Non-Small Cell Lung Cancer
Official title Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma
ClinicalTrials.gov ID: NCT06528847
What this study is testing
What is Benmelstobart?
Benmelstobart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as TQB2450.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join 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...
You likely can't join if
- Postoperative pathological diagnosis of mixed histological features;
- Incomplete resection (R1/R2) or wedge resection, segmentectomy;
- Currently participating in an treatment clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks...
- Systemic corticosteroids or immunosuppressants must have been administered continuously for 7 days within 14 days prior to the first dose of the...
- 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;
See the full eligibility criteria
- 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...
- 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...
- Major organ functions must be normal within 7 days prior to the first dose of the study drug.
- Postoperative pathological diagnosis of mixed histological features;
- Incomplete resection (R1/R2) or wedge resection, segmentectomy;
- Currently participating in an treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.