NCT06299371Not yet recruitingPhase 2
Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
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
Source: ClinicalTrials.gov · Last updated 7 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 15 Apr 2024
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Diseases
- Lung cancer
- NCT number
- NCT06299371
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 15 Apr 2024 to the primary completion date, 15 Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously treated with any anti-tumor therapy;
- 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
- Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
- Prior organ transplantation including allogenic stem-cell transplantation.
Other illness
- 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.
- Subject with previous malignancies within 5 years, except for cured in situ cancer.
- Subject with uncontrolled hypertension.
- Known hypersensitivity to the study drug or any of its excipients.
Other
- 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.
- Other situations that the investigator considers unsuitable for the enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.