Non Small Cell Lung CancerPhase 2NCT06299371
Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
A Phase 2 study testing Adebrelimab, paclitaxel for injection (albumin bound) and Cisplatin or Carboplatin in people with Non Small Cell Lung Cancer, run by Liaoning Cancer Hospital & Institute.
Trial summary
This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Adebrelimab, paclitaxel for injection (albumin bound) and Cisplatin or Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 15 Apr 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Resectable non-small cell lung cancer harboring driver gene mutations.
- At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1.
- Have adequate organ function.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception.
- Voluntarily comply with the treatment protocol.
Who cannot join
- Previously treated with any anti-tumor therapy;
- Subject with known autoimmune disease
- Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
- Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
- Subject with severe liver and kidney dysfunction.
- Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study
Show all 12Show fewer
- Subject with previous malignancies within 5 years, except for cured in situ cancer.
- Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
- Subject with uncontrolled hypertension.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Known hypersensitivity to the study drug or any of its excipients.
- Other situations that the investigator considers unsuitable for the enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations
This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Adebrelimab, paclitaxel for injection (albumin bound), Cisplatin or Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
Adebrelimab IV
paclitaxel for injection (albumin bound)Drug
Also called Nab-paclitaxel
paclitaxel for injection (albumin bound) IV
Cisplatin or CarboplatinDrug
Cisplatin or Carboplatin IV
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant immuno-chemotherapy | Experimental | Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy Receives: Drug: Adebrelimab; Drug: paclitaxel for injection (albumin bound); Drug: Cisplatin or Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)
Measured: at 12 months
Secondary outcomes (6)
Major pathologic response rate
MPR rate, the proportion of patients achieved pathologic complete response (lung and lymph node ≤10% tumor residual assessed by pathology review)
Measured: 12 months
R0 rate
the proportion of patients achieved R0(No residue under the microscope after resection)
Measured: 12 months
Event Free Survival
EFS, the time length from the first dose to any prescriptive events
Measured: up to 5 years
Overall Survival
OS, the time length from the date of the first dose to the date of death.
Measured: up to 5 years
Objective response rate
ORR, the proportion of patients achieved complete or partial response
Measured: 12 months
Adverse Events
AEs
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxu Liu, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299371
- Sponsor's protocol ID
- MA-NSCLC-II-033
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations
- ClinicalTrials.gov ID
- NCT06299371
- Acronym / sponsor ID
- MA-NSCLC-II-033
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 7 Mar 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 is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant immuno-chemotherapy | Experimental | Drug: Adebrelimab, Drug: paclitaxel for injection (albumin bound), Drug: Cisplatin or CarboplatinAdebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Resectable non-small cell lung cancer harboring driver gene mutations.
- At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1.
- Have adequate organ function.
Key exclusion criteria (12 listed)
- Previously treated with any anti-tumor therapy;
- Subject with known autoimmune disease
- Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
- Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
- Subject with severe liver and kidney dysfunction.
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 |
|---|---|---|
| AdebrelimabAlso: SHR-1316Adebrelimab IV | Drug | neoadjuvant immuno-chemotherapy |
| paclitaxel for injection (albumin bound)Also: Nab-paclitaxelpaclitaxel for injection (albumin bound) IV | Drug | neoadjuvant immuno-chemotherapy |
| Cisplatin or CarboplatinCisplatin or Carboplatin IV | Drug | neoadjuvant immuno-chemotherapy |
Primary outcome
Pathological complete response rate
Time frame: at 12 months
pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)
6 secondary outcomes
Major pathologic response rate
Time frame: 12 months
R0 rate
Time frame: 12 months
Event Free Survival
Time frame: up to 5 years
Overall Survival
Time frame: up to 5 years
Objective response rate
Time frame: 12 months
Adverse Events
Time frame: up to 5 years
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 7 Mar 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, paclitaxel for injection (albumin bound) and Cisplatin or Carboplatin in people with Non Small Cell Lung Cancer, run by Liaoning Cancer Hospital & Institute.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Gebang Wang (+8618900918114, gebangdan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.