Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06775275

A Randomized Phase II Study of Adebrelimab with Chemotherapy with or Without Bevacizumab as Neoadjuvant Therapy for Resectable Non-Squamous Non-Small Cell Lung Cancer

Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2025-01-15

60

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adebrelimab combined with chemotherapy, with or without bevacizumab, as a neoadjuvant treatment for adults aged 18 to 65 with resectable Stage II-IIIB non-squamous non-small cell lung cancer (NSQ-NSCLC). This Phase II, randomized, multicenter study aims to explore biomarkers linked to treatment response in this patient group. The trial is sponsored by The First Affiliated Hospital of Guangzhou Medical University and focuses on treatment before surgery to improve outcomes. Participants will receive either a combination of adebrelimab, chemotherapy, and bevacizumab or adebrelimab with chemotherapy alone. The chemotherapy regimens include paclitaxel, albuminotaxol, or docetaxel combined with platinum agents such as carboplatin, cisplatin, or nedaplatin, or pemetrexed combined with platinum. Treatment cycles last three weeks each, with a total of four cycles prior to surgical tumor removal. Surgery is scheduled 4 to 6 weeks after completing neoadjuvant therapy. During the study, participants undergo pathological response assessments within one week after surgery to measure treatment effects. Researchers will also monitor overall response rates before surgery and track event-free survival for up to 24 months. Safety follow-up will occur 30 days after the last bevacizumab or chemotherapy dose or 90 days after the last adebrelimab dose or surgery, whichever is later, to record any adverse events. The total study participation involves treatment, surgery, monitoring, and follow-up evaluations.

CONDITIONS

Brief Title

A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with resectable non-squamous non-small cell lung cancer
  • Aged 18 to 65 years
  • Male or female
  • ECOG performance status of 0 or 1
  • Treatment-naive for surgery, chemotherapy, radiotherapy, and biological therapy
  • Adequate lung function for planned pneumonectomy
Not Eligible

You will not qualify if you...

  • Diagnosis of small cell lung cancer or squamous non-small cell lung cancer
  • Prior use of anti-PD1, anti-PDL1, or anti-CTLA4 antibodies
  • Previous treatment with anti-angiogenic drugs
  • Allergic to any component of study or chemotherapy drugs
  • Presence of any severe or uncontrolled disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 12 weeks (4 cycles of 3 weeks each)

Participants receive neoadjuvant therapy consisting of 4 cycles of adebrelimab combined with chemotherapy, with or without bevacizumab, administered every 3 weeks.

4 treatment visits (in-person), one per cycle

Surgery

Duration - Surgery and immediate recovery over 1 week

Participants undergo surgical resection of the tumor 4 to 6 weeks after completing neoadjuvant therapy.

1 surgery visit (in-person)

Follow-up

Duration - Approximately 1 to 3 months after surgery

Participants are monitored for safety and pathological response after surgery, including a safety follow-up visit 30 to 90 days after last treatment or surgery to track adverse events.

1 safety follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Actively Recruiting

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Research Team

J

Jianxing He

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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