Clinical trial · Interventional

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

NCT06299371CI-TRIAL-00074802not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Adebrelimab	Drug	Adebrelimab	ALIAS
Cisplatin or Carboplatin	Drug	Cisplatin	ALIAS
paclitaxel for injection (albumin bound)	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
neoadjuvant immuno-chemotherapy
description
Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy
interventionNames
1. Drug: Adebrelimab
2. Drug: paclitaxel for injection (albumin bound)
3. Drug: Cisplatin or Carboplatin

Primary outcomes (1)

measure
Pathological complete response rate
timeFrame
at 12 months
description
pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)

Secondary outcomes (6)

measure
Major pathologic response rate

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

References

Publications (0)

Data not yet available

No reference posted for this study.