Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiaoning Cancer Hospital & Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab IV

  • paclitaxel for injection (albumin bound)

    Drug

    paclitaxel for injection (albumin bound) IV

  • Cisplatin or Carboplatin

    Drug

    Cisplatin or Carboplatin IV

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: neoadjuvant immuno-chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
at 12 months

Secondary outcomes

1

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)

Time frame
12 months
2

R0 rate

the proportion of patients achieved R0(No residue under the microscope after resection)

Time frame
12 months
3

Event Free Survival

EFS, the time length from the first dose to any prescriptive events

Time frame
up to 5 years
4

Overall Survival

OS, the time length from the date of the first dose to the date of death.

Time frame
up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: